Quality Engineer Jobs At West Pharmaceutical Services

Candidates who are applying must be residing within a 50-mile commutable distance from the job location. This is a hybrid position (3 days onsite) located at Exton, PA Who We Are: At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary In this role, the Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe and drug containment programs. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets. They will partner with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies and ensure product platforms are compliant with regulatory and business requirements throughout the complete development lifecycle including commercialization, sustainment, and post market surveillance activities. The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. This role is also responsible for Quality oversight of documentation submitted to regulatory authorities in support of commercial launch and life-cycle management. Essential Duties and Responsibilities Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard. Product Development, Risk Management, and Manufacturing: Partner with R&D to provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements, ensuring sustainable and scalable solutions.. Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.) Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures. Partner with R&D to ensure successful design transfers of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers. Additional Responsibilities Quality Management System: Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions Drive proactive, preventative behaviors and via a strong CAPA and to resolve product quality issues for commercialized products. Miscellaneous: Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS. Drive continuous quality improvement projects Other duties as assigned Education Bachelor Degree in Engineering or Science required Relevant work history and/or experience may be considered in lieu of degree Work Experience Minimum 6 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities In-depth knowledge of cGMP regulations, ISO 11040, ISO 15378, ISO 13485, 21 CFR 820, ISO 14971, EU MDR Preferred Knowledge, Skills and Abilities ASQ certification (CQE or CQA) Green or Black Belt certification Experience with MasterControl, SAP, Share Point, Teamcenter Experience with EU GMP Annex I, and PDA a plus Expertise in quality management tools. Standards, policies, and procedures - APQP, PPAP, MSA, SQC etc Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events. Must maintain the ability to work well with others in a variety of situations Maintain high attention to detail, accuracy, and overall quality of work Must be able to multi-task, work under time constraints, problem solve, and prioritize Ability to make independent and sound judgments License and Certifications Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred Quality\Certified Quality Engineer - ASQ (CQE or CQA) Upon Hire preferred ISO 13485 Auditor or Lead Auditor Training / Certification Upon Hire preferred Travel Requirements 10%: Up to 26 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.Additional Requirements Observe and interpret situations, analyze and solve problems Effectively communicate and interface with various levels internally and with customers Strong communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders. Excellent written, critical reading, effective problem solving, and oral communication skills Ability to work independently, multi-task and thrive in fast-paced environment Strong problem-solving skills including root cause failure analysis methods Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities. Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point Be aware of all relevant SOPs as per Company policy as they relate to this role Able to comply with the company's safety policy at all times West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions is hiring a Quality Specialist, Quality Management Systems. The Quality Specialist, Quality Management Systems must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. The Quality Specialist, Quality Management Systems must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. The Quality Specialist, Quality Management Systems is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards This is a full-time role position: Monday-Friday 8:00am-5:00pm. Salary Role, Onsite Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role Lead Document Management site program (hardcopies, EDMS). Interact with other divisions of Catalent in regard to record retention policies and document management and control. Leads the Training Program for GMP Training, Procedural based training, and other training need for performing tasks. Site administrator for Trackwise, EDMS and ComplianceWire Lead the revisions and implementation of Catalent Global standard updates for the site. Lead completion of Annual Product Quality Review documents on schedule, as required. Schedule, prepare for and lead customer audits through response and audit closure. Assist in preparing, supporting and closure of the site for inspection by regulatory authorities. Develop new procedures, and review and update existing procedures. Represent QA on project teams and other internal forums. Use and extract information from the following systems: EDMS, TrackWise, and ComplianceWire Work closely with site on Trackwise compliance and timeliness of responses. Site Pathwise representative. Completion of QMR presentation and minutes Reporting of monthly Quality metrics. Lead Supplier program (qualification, requalification, complaints, technical agreements). Lead Internal Audit program. Lead Quality Technical Agreements for the site with client. Manage Iron Mountain and record retention Backup for DEA and State Licensing program All other duties as assigned; The Candidate Required a High School Diploma with Five years of experience working in a regulated environment, such as, food, aero, automotive, pharma. Bachelors Degree highly preferred Candidate must have computer skills with MS Office and capable of quickly learning other software including EDMS, TrackWise and ComplianceWire. Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions is hiring a Quality Specialist, Quality Management Systems. The Quality Specialist, Quality Management Systems must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. The Quality Specialist, Quality Management Systems must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. The Quality Specialist, Quality Management Systems is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards **This is a full-time role position:** **Monday-Friday 8:00am-5:00pm. Salary Role,** **Onsite** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role** + Lead Document Management site program (hardcopies, EDMS). Interact with other divisions of Catalent in regard to record retention policies and document management and control. + Leads the Training Program for GMP Training, Procedural based training, and other training need for performing tasks. Site administrator for Trackwise, EDMS and ComplianceWire + Lead the revisions and implementation of Catalent Global standard updates for the site. Lead completion of Annual Product Quality Review documents on schedule, as required. Schedule, prepare for and lead customer audits through response and audit closure. + Assist in preparing, supporting and closure of the site for inspection by regulatory authorities. + Develop new procedures, and review and update existing procedures. Represent QA on project teams and other internal forums. Use and extract information from the following systems: EDMS, TrackWise, and ComplianceWire + Work closely with site on Trackwise compliance and timeliness of responses. Site Pathwise representative. Completion of QMR presentation and minutes + Reporting of monthly Quality metrics. Lead Supplier program (qualification, requalification, complaints, technical agreements). Lead Internal Audit program. Lead Quality Technical Agreements for the site with client. Manage Iron Mountain and record retention + Backup for DEA and State Licensing program + All other duties as assigned; **The Candidate** + Required a High School Diploma with Five years of experience working in a regulated environment, such as, food, aero, automotive, pharma. + Bachelors Degree highly preferred + Candidate must have computer skills with MS Office and capable of quickly learning other software including EDMS, TrackWise and ComplianceWire. + Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions is hiring a Quality Specialist, Quality Management Systems. The Quality Specialist, Quality Management Systems must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. The Quality Specialist, Quality Management Systems must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. The Quality Specialist, Quality Management Systems is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards This is a full-time role position: Monday-Friday 8:00am-5:00pm. Salary Role, Onsite Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role * Lead Document Management site program (hardcopies, EDMS). Interact with other divisions of Catalent in regard to record retention policies and document management and control. * Leads the Training Program for GMP Training, Procedural based training, and other training need for performing tasks. Site administrator for Trackwise, EDMS and ComplianceWire * Lead the revisions and implementation of Catalent Global standard updates for the site. Lead completion of Annual Product Quality Review documents on schedule, as required. Schedule, prepare for and lead customer audits through response and audit closure. * Assist in preparing, supporting and closure of the site for inspection by regulatory authorities. * Develop new procedures, and review and update existing procedures. Represent QA on project teams and other internal forums. Use and extract information from the following systems: EDMS, TrackWise, and ComplianceWire * Work closely with site on Trackwise compliance and timeliness of responses. Site Pathwise representative. Completion of QMR presentation and minutes * Reporting of monthly Quality metrics. Lead Supplier program (qualification, requalification, complaints, technical agreements). Lead Internal Audit program. Lead Quality Technical Agreements for the site with client. Manage Iron Mountain and record retention * Backup for DEA and State Licensing program * All other duties as assigned; The Candidate * Required a High School Diploma with Five years of experience working in a regulated environment, such as, food, aero, automotive, pharma. * Bachelors Degree highly preferred * Candidate must have computer skills with MS Office and capable of quickly learning other software including EDMS, TrackWise and ComplianceWire. * Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds Why you should join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * Positive working environment focusing on continually improving processes to remain innovative * Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives * 152 hours of PTO + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment * Community engagement and green initiatives * Generous 401K match * Medical, dental and vision benefits effective day one of employment * Tuition Reimbursement - Let us help you finish your degree or start a new degree! * WellHub- program to promote overall physical wellness * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Manager. The Manager is responsible for coordinating and implementing activities to attain strategic objectives within a single functional area or department and looks to his or her direct supervisor or other peers within the industry for guidance. This is a full-time, salaried role, on-site. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Write, revise, and/or review SOPs for approval Assist in preparing the site for inspection by regulatory authorities and participating in regulatory inspections, as required Assign project deliverables to team members with appropriate due dates for project completion Provide team members with leadership, guidance, mentoring, coaching and feedback against performance and development objectives Review and approve quality records in TrackWise Conduct performance reviews, recommend salary increases, and career planning for all direct reports Represent quality department on project teams, management teams and other internal forums All other duties as assigned The Candidate: Bachelor of Science Degree is required At least ten years of experience working in Quality areas in the Pharmaceutical/medical device industry with management responsibilities is preferred Experienced working in a cGMP management role with an understanding of compliance and associated regulations is preferred Good computer skills, including in-depth knowledge of MS Office, Electronic Document Management Systems (EDMS), TrackWise and ComplianceWire preferred In-depth knowledge of Quality Assurance and Regulatory Affairs as applicable to the Pharmaceutical industry Required Leadership skills include excellent interpersonal and communication skills with cross-functional teams, the strong ability to lead, mentor, train, motivate, direct and empower a team, influence and lead change, and contribute strategic, analytical insight for problem solving and work with the team to identify gaps and develop continuous improvement suggestions/ideas Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Why You Should Join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Company match on donations to organizations Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring a Supplier Quality Specialist. The Supplier Quality Specialist will assure compliance to national and international standards by managing or completing tasks that support the Global Comparator and Depot Supplier Quality Management and Clinical Packaging Network site Supplier Programs. They will support and participate or lead in the maintenance of the audit schedule and approved supplier list. This is a full-time, on-site salary position: Monday - Friday, 1st shift. This position can be located at our Kansas City, Philadelphia or San Diego sites. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role * Manage the approved supplier list for Global Supplier Quality and network supplier programs * Plan, conduct, review and report supplier site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures * Ensure supplier records are initiated and maintained for all supplier approval documentation including audits, assessments, and quality agreements * Complete and assist in completion of Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up's * Evaluate and perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls) * Monitor/support supplier license renewal for applicable services * Liaise with suppliers to ensure compliance to regulatory changes or updates (globally) * All other duties as assigned The Candidate: * A High School Diploma or General Education Diploma with at least six years of experience in Quality or Pharmaceutical is required; A Bachelor's Degree with at least two years of experience in pharmaceutical quality is preferred * Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred * Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred * Demonstrate project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals * Prior experience in JDE and Trackwise systems preferred * Position is site based and candidate must be able to commute to one of the Clinical packaging sites at Catalent located in the US region (San Diego, PHL or KCM) * Ability to travel both domestic and abroad to Catalent sites or Catalent supplier locations as required ~25% travel * Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements include reading of written documents, visual inspection of materials and use of computer monitor screen frequently Why you should join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * Positive working environment focusing on continually improving processes to remain innovative * Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives * 152 Hours + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment * Community engagement and green initiatives * Generous 401K match * Company match on donations to organizations * Medical, dental and vision benefits effective day one of employment * Tuition Reimbursement - Let us help you finish your degree or start a new degree! * WellHub program to promote overall physical wellness * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring a Supplier Quality Specialist. The Supplier Quality Specialist will assure compliance to national and international standards by managing or completing tasks that support the Global Comparator and Depot Supplier Quality Management and Clinical Packaging Network site Supplier Programs. They will support and participate or lead in the maintenance of the audit schedule and approved supplier list. **This is a full-time, on-site salary position: Monday - Friday, 1st shift. This position can be located at our Kansas City, Philadelphia or San Diego sites.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role** + Manage the approved supplier list for Global Supplier Quality and network supplier programs + Plan, conduct, review and report supplier site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures + Ensure supplier records are initiated and maintained for all supplier approval documentation including audits, assessments, and quality agreements + Complete and assist in completion of Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up's + Evaluate and perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls) + Monitor/support supplier license renewal for applicable services + Liaise with suppliers to ensure compliance to regulatory changes or updates (globally) + All other duties as assigned **The Candidate:** + A High School Diploma or General Education Diploma with at least six years of experience in Quality or Pharmaceutical is required; A Bachelor's Degree with at least two years of experience in pharmaceutical quality is preferred + Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred + Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred + Demonstrate project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals + Prior experience in JDE and Trackwise systems preferred + Position is site based and candidate must be able to commute to one of the Clinical packaging sites at Catalent located in the US region (San Diego, PHL or KCM) + Ability to travel both domestic and abroad to Catalent sites or Catalent supplier locations as required ~25% travel + **Physical Requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements include reading of written documents, visual inspection of materials and use of computer monitor screen frequently **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia is hiring a Senior Engineer, Quality Operations. This position reports to the Quality Assurance Manager and provides Quality Assurance guidance and support for activities related to Manufacturing and Packaging operations at Catalent Philadelphia. Supports regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures. Responsible for performing/reviewing product quality complaint investigations, process deviations, and validation protocols. Responsible for overseeing special projects, compliance issues and providing possible corrective actions to remedy the issues and prevent future occurrences. The Senior Engineer, Quality Operations will have no direct reports. The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures. The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations. **This is a full-time role position: Monday-Friday:** **8:00am-5:00pm** **-1st shift. Onsite** **.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Provides Quality Assurance (QA) support and oversight (including approval) for improvement projects, change requests, quality issue resolution, CAPAs, process control, validations, and data integrity assessments + Understands and partners with Quality/Production/Project Management/ CI in the management and improvement of Quality-related metrics (Power BI), trending, strategic improvements as for deviations, complaints, change controls, etc + Partners with Production personnel to encourage and implement a 'build in' Quality rather than 'inspect in' Quality culture + Partners with Production/ Project Management to identify operating efficiencies to continuously improve and promote compliance + Educates Quality/ Production/ Project Management on regulatory and customer requirements which impact upon the achievement of appropriate quality and compliance standards at the facility + Drives, influences, and approves timely completion of product quality investigations, process or procedural deviations, and other quality system reports in TrackWise (as applicable), as well as timely review and approval of those reports completed by Production + Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various statistical and non-statistical problem-solving tools as part of analysis + All other duties as assigned **The Candidate:** + Requires a Bachelor's Degree in Science or Engineering discipline with at least two years of relevant experience; OR an Associate's Degree with at least four years of relevant experience; OR a High School Diploma / GED with at least eight years of relevant experience + Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment is preferred + Experience in a regulated, pharmaceutical field is strongly preferred + Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is preferred + Basic knowledge of Lean Six Sigma methodologies an advantage + Challenges the status quo and understands and drives continuous improvement + Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds **Why You Should Join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia is hiring a Senior Engineer, Quality Operations. This position reports to the Quality Assurance Manager and provides Quality Assurance guidance and support for activities related to Manufacturing and Packaging operations at Catalent Philadelphia. Supports regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures. Responsible for performing/reviewing product quality complaint investigations, process deviations, and validation protocols. Responsible for overseeing special projects, compliance issues and providing possible corrective actions to remedy the issues and prevent future occurrences. The Senior Engineer, Quality Operations will have no direct reports. The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures. The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations. This is a full-time role position: Monday-Friday: 8:00am-5:00pm -1st shift. Onsite. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Provides Quality Assurance (QA) support and oversight (including approval) for improvement projects, change requests, quality issue resolution, CAPAs, process control, validations, and data integrity assessments Understands and partners with Quality/Production/Project Management/ CI in the management and improvement of Quality-related metrics (Power BI), trending, strategic improvements as for deviations, complaints, change controls, etc Partners with Production personnel to encourage and implement a ‘build in' Quality rather than ‘inspect in' Quality culture Partners with Production/ Project Management to identify operating efficiencies to continuously improve and promote compliance Educates Quality/ Production/ Project Management on regulatory and customer requirements which impact upon the achievement of appropriate quality and compliance standards at the facility Drives, influences, and approves timely completion of product quality investigations, process or procedural deviations, and other quality system reports in TrackWise (as applicable), as well as timely review and approval of those reports completed by Production Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various statistical and non-statistical problem-solving tools as part of analysis All other duties as assigned The Candidate: Requires a Bachelor's Degree in Science or Engineering discipline with at least two years of relevant experience; OR an Associate's Degree with at least four years of relevant experience; OR a High School Diploma / GED with at least eight years of relevant experience Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment is preferred Experience in a regulated, pharmaceutical field is strongly preferred Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is preferred Basic knowledge of Lean Six Sigma methodologies an advantage Challenges the status quo and understands and drives continuous improvement Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Why You Should Join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 Hours + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Company match on donations to organizations Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia is hiring a Senior Engineer, Quality Operations. This position reports to the Quality Assurance Manager and provides Quality Assurance guidance and support for activities related to Manufacturing and Packaging operations at Catalent Philadelphia. Supports regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures. Responsible for performing/reviewing product quality complaint investigations, process deviations, and validation protocols. Responsible for overseeing special projects, compliance issues and providing possible corrective actions to remedy the issues and prevent future occurrences. The Senior Engineer, Quality Operations will have no direct reports. The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures. The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations. This is a full-time role position: Monday-Friday: 8:00am-5:00pm -1st shift. Onsite. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Provides Quality Assurance (QA) support and oversight (including approval) for improvement projects, change requests, quality issue resolution, CAPAs, process control, validations, and data integrity assessments * Understands and partners with Quality/Production/Project Management/ CI in the management and improvement of Quality-related metrics (Power BI), trending, strategic improvements as for deviations, complaints, change controls, etc * Partners with Production personnel to encourage and implement a 'build in' Quality rather than 'inspect in' Quality culture * Partners with Production/ Project Management to identify operating efficiencies to continuously improve and promote compliance * Educates Quality/ Production/ Project Management on regulatory and customer requirements which impact upon the achievement of appropriate quality and compliance standards at the facility * Drives, influences, and approves timely completion of product quality investigations, process or procedural deviations, and other quality system reports in TrackWise (as applicable), as well as timely review and approval of those reports completed by Production * Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various statistical and non-statistical problem-solving tools as part of analysis * All other duties as assigned The Candidate: * Requires a Bachelor's Degree in Science or Engineering discipline with at least two years of relevant experience; OR an Associate's Degree with at least four years of relevant experience; OR a High School Diploma / GED with at least eight years of relevant experience * Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment is preferred * Experience in a regulated, pharmaceutical field is strongly preferred * Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is preferred * Basic knowledge of Lean Six Sigma methodologies an advantage * Challenges the status quo and understands and drives continuous improvement * Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Why You Should Join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * Positive working environment focusing on continually improving processes to remain innovative * Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives * 152 Hours + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment * Community engagement and green initiatives * Generous 401K match * Company match on donations to organizations * Medical, dental and vision benefits effective day one of employment * Tuition Reimbursement - Let us help you finish your degree or start a new degree! * WellHub program to promote overall physical wellness * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

The Barrier Operations Technical Operations team is seeking a highly motivated individual to provide technical and engineering support as Senior Specialist process engineer. Areas within scope of Barrier Operations include multi-product liquid vaccine formulation (closed processing), aseptic vial filling, and aseptic syringe filling. The successful candidate will have the opportunity to apply his or her enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation and improvement of a vaccine manufacturing facility with a focus on process engineering. **Responsibilities may include:** + Serves as the subject matter expert (SME) for a liquid vaccine manufacturing process within Barrier Operations + Monitors process and equipment performance, and partners with maintenance/operation's/ reliability engineering to proactively identify and implement process improvements + Provides assessment of impact for proposed changes to manufacturing steps or equipment + Supports or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times + Collaborates effectively with the area, operators/mechanics, support groups, Quality, planning, project teams, and external component and equipment vendors + Provides direct shopfloor support or mentors others in response to shop floor events and process upsets, including input to deviation management and product leads + Support of regulator inspections and compliance driven actions + Leads technical discussions, and maintains technical process documentation + Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, protocols, and change control + Supports team safety, environmental, and compliance objective + Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies. + Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible. **Minimum Education Requirement and Experience:** + Bachelor of Science (B.S.) degree in Engineering or Science field (i.e. chemical engineering, biochemical engineering, mechanical engineering, biological system engineering) with five (5) years of experience in a GMP functional area or support, such as, Operations, Technical Operations, Engineering, and/or Maintenance. **Required Experience and Skills:** + Strong verbal and written communication skills; interpersonal and team skills; and collaborative skills + Demonstrated ability to proactively identify and implement process improvements + Excellent troubleshooting and problem-solving skills + Demonstrated technical, analytical, and organization skills + Experience in supporting vaccine manufacturing or sterile processing + Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing **Preferred Experience and Skills:** + Aseptic filling experience, specifically vial filling or syringe filling line + Change control author or approver + Project management experience + Regulatory inspection experience + Strong leadership skills Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Required Skills:** Adaptability, Adaptability, Biological Engineering, Biological System, Biomedical Engineering, Change Control Processes, Cost Reduction, Customer-Oriented, Deviation Management, Electromechanical Engineering, Engineering Standards, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Processes, Manufacturing Process Improvements, Manufacturing Process Validation, Mechanical Engineering, Mechatronics, Process Engineering, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork {+ 2 more} **Preferred Skills:** **Job Posting End Date:** 06/24/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R353322

The Barrier Operations Technical Operations team is seeking a highly motivated individual to provide technical and engineering support as Senior Specialist process engineer. Areas within scope of Barrier Operations include multi-product liquid vaccine formulation (closed processing), aseptic vial filling, and aseptic syringe filling. The successful candidate will have the opportunity to apply his or her enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation and improvement of a vaccine manufacturing facility with a focus on process engineering. Responsibilities may include: Serves as the subject matter expert (SME) for a liquid vaccine manufacturing process within Barrier Operations Monitors process and equipment performance, and partners with maintenance/operation's/ reliability engineering to proactively identify and implement process improvements Provides assessment of impact for proposed changes to manufacturing steps or equipment Supports or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times Collaborates effectively with the area, operators/mechanics, support groups, Quality, planning, project teams, and external component and equipment vendors Provides direct shopfloor support or mentors others in response to shop floor events and process upsets, including input to deviation management and product leads Support of regulator inspections and compliance driven actions Leads technical discussions, and maintains technical process documentation Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, protocols, and change control Supports team safety, environmental, and compliance objective Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies. Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible. Minimum Education Requirement and Experience: Bachelor of Science (B.S.) degree in Engineering or Science field (i.e. chemical engineering, biochemical engineering, mechanical engineering, biological system engineering) with five (5) years of experience in a GMP functional area or support, such as, Operations, Technical Operations, Engineering, and/or Maintenance. Required Experience and Skills: Strong verbal and written communication skills; interpersonal and team skills; and collaborative skills Demonstrated ability to proactively identify and implement process improvements Excellent troubleshooting and problem-solving skills Demonstrated technical, analytical, and organization skills Experience in supporting vaccine manufacturing or sterile processing Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing Preferred Experience and Skills: Aseptic filling experience, specifically vial filling or syringe filling line Change control author or approver Project management experience Regulatory inspection experience Strong leadership skills Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Adaptability, Adaptability, Biological Engineering, Biological System, Biomedical Engineering, Change Control Processes, Cost Reduction, Customer-Oriented, Deviation Management, Electromechanical Engineering, Engineering Standards, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Processes, Manufacturing Process Improvements, Manufacturing Process Validation, Mechanical Engineering, Mechatronics, Process Engineering, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork {+ 2 more} Preferred Skills: Job Posting End Date: 06/24/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**_What Quality Assurance / Supplier Quality Management contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. **_Job Summary_** The Senior Principal Specialist, executes programs, policies, and procedures within the area of quality to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Principal Specialist supports the Manager, Quality Assurance in overseeing the Supplier Qualification Program. Through this program, the Senior Principal Specialist develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Principal Specialist mentors junior Specialists. **_Responsibilities_** + Oversee and participate in the overall Supplier Qualification Program and Lifecycle Management of Suppliers for Cardinal Health Pharmaceutical Private Label, consisting of the following: (1) Risk Assessment Program, (2) Audit Program, (3) Maintenance of Quality Agreements, and (4) Maintenance of the Approved Supplier List. + Risk Assessments: Gathers and/or verifies data obtained from various regulatory and internal sources to determine Supplier risk profiles. + Audit Program: Develop annual audit schedules, review audit reports, ensure adequacy of supplier responses to audit observations, and assess qualification state of Supplier. May conduct or participate in audits. + Quality Agreements: Reviews, comments and challenges in an appropriate way, feedback provided from Supplier for Quality Agreement content. + Approved Supplier List: Qualifies supplies in compliance with internal procedures and in compliance with regulatory requirements. + Lifecycle Management: Ongoing monitoring and oversight of supplier quality performance (i.e. through metrics, trending SCARs, etc.) + Developing metrics for Suppliers to identify positive or adverse trends and/or identifying acute issues, which will be utilized to engage management review for suppliers, as needed. + Enhances the current Supplier Corrective Action Report (SCAR) process and updates SOPs by identification of major and/or critical gaps to the Quality Agreement. + Escalates complex issues to management in a timely manner. + Prioritizes and ensures work is delivered in an efficient way. Receives general guidance and may receive more detailed instruction on new projects + Represents QA in meeting related to his/her area of responsibility + Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service. + Takes actions to continually improve quality in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback. + Role models Cardinal Health's high ethical standards and code of conduct and models the characteristics outlined in the Cardinal Health Leadership Essentials- Managers of People, Process, or Projects. + Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements. + Performs other job duties as assigned. **_Experience_** + 4-8 years of experience in a regulated pharmaceutical GMP environment, preferably manufacturing. + BA, BS or equivalent experience in related field preferred + Applies working knowledge in the application of supplier quality /quality systems concepts, principles, and technical capabilities to perform varied tasks. + Demonstrates an understanding of the relevant FDA regulations, standards and operating procedures for supplier qualifications including, but not limited to drugs, medical devices, and dietary supplements. + Demonstrates an understanding of the requirements and can perform gap assessments to those requirements. + Identifies possible solutions to a variety of identified quality issues and takes action to resolve. + Effectively interpret the requirements and communicate to upstream suppliers, colleagues, and downstream service providers to ensure prompt attention to identify quality and service-oriented solutions and/or identified quality issues. + Educate the influence others on quality issues and requirements. + Must be comfortable making decisions that may conflict with production priorities and must implement and communicate these decisions in an effective, diplomatic and professional manner. + Must be detail oriented and very conscientious. + Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. + Experience using electronic Quality Management Systems. + ASQ certification is strongly preferred. + Experience auditing suppliers and/or vendors is strongly preferred. **Anticipated salary range:** $79,300 - $113,800 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 8/13/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

**Candidates who are applying must be residing within a 50-mile commutable distance from the job location. This is a hybrid position (3 days onsite) located at Exton, PA** **Who We Are:** At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. **Job Summary** In this role, the Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe and drug containment programs. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets. They will partner with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies and ensure product platforms are compliant with regulatory and business requirements throughout the complete development lifecycle including commercialization, sustainment, and post market surveillance activities. The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. This role is also responsible for Quality oversight of documentation submitted to regulatory authorities in support of commercial launch and life-cycle management. **Essential Duties and Responsibilities** + Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard. + **Product Development, Risk Management, and Manufacturing** : + Partner with R&D to provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements, ensuring sustainable and scalable solutions.. + Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.) + Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation + Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures. + Partner with R&D to ensure successful design transfers of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers. **Additional Responsibilities** + **Quality Management System** : + Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions + Drive proactive, preventative behaviors and via a strong CAPA and to resolve product quality issues for commercialized products. + **Miscellaneous:** + Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS. + Drive continuous quality improvement projects + Other duties as assigned **Education** + Bachelor Degree in Engineering or Science required + Relevant work history and/or experience may be considered in lieu of degree **Work Experience** + Minimum 6 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities + In-depth knowledge of cGMP regulations, ISO 11040, ISO 15378, ISO 13485, 21 CFR 820, ISO 14971, EU MDR **Preferred Knowledge, Skills and Abilities** + ASQ certification (CQE or CQA) + Green or Black Belt certification + Experience with MasterControl, SAP, Share Point, Teamcenter + Experience with EU GMP Annex I, and PDA a plus + Expertise in quality management tools. Standards, policies, and procedures - APQP, PPAP, MSA, SQC etc + Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events. + Must maintain the ability to work well with others in a variety of situations + Maintain high attention to detail, accuracy, and overall quality of work + Must be able to multi-task, work under time constraints, problem solve, and prioritize + Ability to make independent and sound judgments **License and Certifications** + Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred + Quality\Certified Quality Engineer - ASQ (CQE or CQA) Upon Hire preferred + ISO 13485 Auditor or Lead Auditor Training / Certification Upon Hire preferred **Travel Requirements** 10%: Up to 26 business days per year **Physical Requirements** Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. **Additional Requirements** + Observe and interpret situations, analyze and solve problems + Effectively communicate and interface with various levels internally and with customers + Strong communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders. + Excellent written, critical reading, effective problem solving, and oral communication skills + Ability to work independently, multi-task and thrive in fast-paced environment + Strong problem-solving skills including root cause failure analysis methods + Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities. + Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point + Be aware of all relevant SOPs as per Company policy as they relate to this role + Able to comply with the company's safety policy at all times West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, inclusion, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Global Engineering Solutions (GES) is responsible for the design, construction, and delivery of advanced manufacturing facilities and laboratories worldwide. We provide premier engineering solutions in the pharmaceutical industry through technical innovation and project management to deliver important life-saving medicines and vaccines to patients. With our extensive range of facilities and environments, our Engineers have opportunities to impact diverse areas within Large and Small Molecule within our Manufacturing Division and Animal Health lines of business, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Our Engineers provide solutions for internal and external manufacturing needs in support of operational efficiencies, continuous improvement, and innovations. This position in Global Engineering Solutions (GES) will help the successful candidate develop the sound leadership, communication, and technical skills needed to be successful in a fast-paced engineering environment. The Future Talent Program features co-operative assignments that last up to 6 months and will include one or more primary assignments as well as smaller secondary assignments. These opportunities can provide you with great development and a chance to see if we are the right company for your long-term goals. This Engineering Co-op position is targeted for college students in their Junior or Senior year. The role involves learning and applying skills related to process engineering of pharmaceutical grade equipment for use in drug product and drug substance manufacturing. We are seeking candidates with outstanding academic records of achievement and demonstrated leadership abilities, candidates who are analytical and inquisitive about the interrelationships of various components, and perceptive, quick learners committed to making a difference in the pursuit of manufacturing high-quality, market-leading pharmaceutical and vaccine products. The successful candidate's area of focus and specific assignments will be determined by business need at and during the co-op duration. The specific assignments and responsibilities will be determined closer to the co-op start date. During the assignment, general responsibilities include but are not limited to: The co-op employee will be challenged to apply their technical knowledge and data analysis and troubleshooting skills in the support of pharmaceutical manufacturing processes and facilities, in a team-based environment. The ideal candidate will possess superior communication and interpersonal skills, a team player with the ability to work independently. The co-op candidate will be offered the opportunity to develop their leadership skills in the areas of diverse team building, vendor management, and process equipment development/design. The co-op will be provided coaching with assignment managers, mentors, and a “buddy.” Prior experience with capital equipment specification and installation are preferred. Candidates possessing prior intern or co-op experience in a pharmaceutical engineering role will be given clear preference. Education Minimum Requirement: This position is targeted for candidates in their Junior or Senior year at an accredited college/university. Candidates must be currently pursuing a bachelor's or master's degree in Engineering (e.g. Chemical, Biomedical, Mechanical, etc.) or equivalent discipline. No prior experience is required. Candidates must be U.S. citizens or lawful permanent resident of U.S. Preferred Experience and Skills: Ideal candidate will possess superior communication and interpersonal skills, a team player with the ability to work independently. Candidates should have effective collaboration, written and oral communication, and problem-solving skills with desire to be innovative. Candidate must possess motivation, dependability, systems thinking and active listening. Prior experience with capital equipment specification and installation are preferred but not required. Candidates possessing prior intern or co-op experience in a Pharmaceutical engineering role will be given clear preference. Prior intern or co-op experience in the manufacturing or engineering sector, preferably in the Pharmaceutical sector. FTP2025 MMD2025 Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Required Skills: Preferred Skills: Job Posting End Date: 06/24/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia, PA is hiring a Packaging Engineer. This is a full-time, onsite, salaried role: Monday-Friday. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Works with internal staff and customers, as needed, to design functional packaging designs and recommend materials to run efficiently on production equipment. Creates preliminary graphic designs for blister cards and cartons. Produces blister card, partition, carton, and pouch samples, utilizing onsite sample lab, support clients and project management. Determine label sizes and verify label fit on components liaising with Label Control. Prepare pictorial diagrams in support of label placement and kit assembly instructions for batch records Generates drug placement diagrams for production to follow when assembling / sealing blister cards in secondary, also includes design/creation of blister card sealing templates for heat sealing machines to prevent product mix-up. Ability to troubleshoot problems with designs and determine / initiate corrective actions. Collaborate with engineering, production and quality assurance teams to develop and implement packaging processes on the production floor. Monitor and analyze critical process performance and develop strategies to meet or exceed targets. Provide technical support and troubleshooting expertise to resolve process-related issues and improve overall equipment effectiveness (OEE). Participate in cross-functional teams to drive root cause analysis, corrective actions and preventive measures. Other tasks or projects as assigned. The Candidate: Requires a Bachelor's degree, preferrable in Packaging Engineering, with at least one year of relevant work experience; OR a High School Diploma/GED with at least five years of relevant work experience Requires experience in Microsoft Office Must have a familiarity with production equipment and Manufacturing processes Strongly prefer experience in AutoCAD, ArtiosCAD, and Adobe Photoshop Prefer at least two years of experience in clinical or commercial packaging Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia, PA is hiring a Packaging Engineer. **This is a full-time, onsite, salaried role: Monday-Friday.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Works with internal staff and customers, as needed, to design functional packaging designs and recommend materials to run efficiently on production equipment. + Creates preliminary graphic designs for blister cards and cartons. + Produces blister card, partition, carton, and pouch samples, utilizing onsite sample lab, support clients and project management. + Determine label sizes and verify label fit on components liaising with Label Control. + Prepare pictorial diagrams in support of label placement and kit assembly instructions for batch records + Generates drug placement diagrams for production to follow when assembling / sealing blister cards in secondary, also includes design/creation of blister card sealing templates for heat sealing machines to prevent product mix-up. + Ability to troubleshoot problems with designs and determine / initiate corrective actions. + Collaborate with engineering, production and quality assurance teams to develop and implement packaging processes on the production floor. + Monitor and analyze critical process performance and develop strategies to meet or exceed targets. + Provide technical support and troubleshooting expertise to resolve process-related issues and improve overall equipment effectiveness (OEE). + Participate in cross-functional teams to drive root cause analysis, corrective actions and preventive measures. + Other tasks or projects as assigned. **The Candidate:** + Requires a Bachelor's degree, preferrable in Packaging Engineering, with at least one year of relevant work experience; OR a High School Diploma/GED with at least five years of relevant work experience + Requires experience in Microsoft Office + Must have a familiarity with production equipment and Manufacturing processes + Strongly prefer experience in AutoCAD, ArtiosCAD, and Adobe Photoshop + Prefer at least two years of experience in clinical or commercial packaging + Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia, PA is hiring a Packaging Engineer. This is a full-time, onsite, salaried role: Monday-Friday. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Works with internal staff and customers, as needed, to design functional packaging designs and recommend materials to run efficiently on production equipment. * Creates preliminary graphic designs for blister cards and cartons. * Produces blister card, partition, carton, and pouch samples, utilizing onsite sample lab, support clients and project management. * Determine label sizes and verify label fit on components liaising with Label Control. * Prepare pictorial diagrams in support of label placement and kit assembly instructions for batch records * Generates drug placement diagrams for production to follow when assembling / sealing blister cards in secondary, also includes design/creation of blister card sealing templates for heat sealing machines to prevent product mix-up. * Ability to troubleshoot problems with designs and determine / initiate corrective actions. * Collaborate with engineering, production and quality assurance teams to develop and implement packaging processes on the production floor. * Monitor and analyze critical process performance and develop strategies to meet or exceed targets. * Provide technical support and troubleshooting expertise to resolve process-related issues and improve overall equipment effectiveness (OEE). * Participate in cross-functional teams to drive root cause analysis, corrective actions and preventive measures. * Other tasks or projects as assigned. The Candidate: * Requires a Bachelor's degree, preferrable in Packaging Engineering, with at least one year of relevant work experience; OR a High School Diploma/GED with at least five years of relevant work experience * Requires experience in Microsoft Office * Must have a familiarity with production equipment and Manufacturing processes * Strongly prefer experience in AutoCAD, ArtiosCAD, and Adobe Photoshop * Prefer at least two years of experience in clinical or commercial packaging * Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Why you should join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * Positive working environment focusing on continually improving processes to remain innovative * Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives * 152 hours of PTO + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment * Community engagement and green initiatives * Generous 401K match * Medical, dental and vision benefits * Tuition Reimbursement - Let us help you finish your degree or start a new degree! * WellHub- program to promote overall physical wellness * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Work Your Magic with us! Start your next chapter and join EMD Electronics. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Location: The Senior Process Engineer is an onsite position in Tamaqua, PA. Approximately 10% domestic and international travel is required to support business needs. Your Role: As a Senior Process Engineer for Specialty Gases you are the owner of our manufacturing processes assigned to you. You are responsible for defining the processes in close collaboration with Process Development and Global Engineering for manufacturing a product newly introduced into our portfolio/network. After project closure, you will become the local on-site Process Engineer owning the continuous improvement of the respective process. You will be identifying improvement ideas, developing the relevant projects and executing them in accordance with the priorities defined by Asset Management utilizing the DMAIC process, Lean & Six-Sigma methodology, data analytics and digital tools available and going through the final management of change (MOC) prior to implementing the results. You will be an essential part of the team analyzing root causes of process, safety or quality excursions as well as of new product introductions, DHR and OPHR activities. You are responsible for capturing technology and process data and history, key insights and lessons learned utilizing the available documentation systems and making the data accessible and processable for the respective data analytics tools. This role will be an essential part of the global Centers of Excellence for Continuous Improvement within the Specialty Gases Operations team which explicitly includes supporting developing and executing business critical and prioritized CI-projects at other sites globally. Key Responsibilities: Support process development from initial engineering feasibility through manufacturing implementation including verification and validation activities, equipment qualification, and initial production. Perform system optimization, upgrades and improvements utilizing continuous improvement and Six Sigma methodologies. Regulatory and corporate standards compliance Support investigating and resolving corrective action requests Review and update process and operation documentation Assess processes, take measurements, and interpret data Identification and implementation of cost savings initiatives in manufacturing and QC processes Design, run, test and upgrade systems and processes; identifying Continuous Improvement opportunities and engineering them effectively into the product lines Develop best practices, routines and innovative solutions to improve production rates and quality of output Responsible for material balancing of assigned processes to include raw material, product and waste streams Drive operations improvement programs, implement SPC/SQC and other statistical techniques to monitor and reduce variation in manufacturing processes, and develop and conduct training to support this effort. Support SPC/SQC data requirements for both commercialized and pre-commercialized materials. Develop data bases for customized control charts that include raw material, supplier data, in process, finished goods and C of A parameters. Supporting MOC (management of change) activity related to product lines. Support troubleshooting efforts in the event of quality excursions; lead customer interface for quality task forces and drive closure and customer satisfaction. Who You Are Minimum Qualifications: 5+ years of experience and a BS in Chemical Engineering or Process Technology Strong leadership, organizational, computer, and interpersonal skills combined with good communications skills Able to work within a matrixed engineering management team environment and partner effectively with team members, project managers, and customers Preferred Qualifications: MS or PhD in Chemical Engineering Lean & Six Sigma Certified - Green Belt as a minimum, Black Belt or Master Black Belt certification is preferred - knowledge and applied experience with problem solving and of DFSS, DMAIC, RCCA, FMEA Background in Data Science with data analytics capability (applied experience with SPC/SQC and other statistical techniques Continuous improvement experience Combined 10+ years of experience in chemical operations and process design Experience and knowledge in the technology transfer from small to large scale Experience and knowledge in commissioning & start-up activities for projects Experience and knowledge in the technology and/or operation of systems used in the manufacture, purification, filling and storage of electronic chemicals A working comprehension and experience of semiconductor requirements for materials, packaging, products, and processes Understanding of manufacturing processes and materials of construction for Electronics Materials production American Society for Quality (ASQ) and/or Certified Quality Engineer (CQE) ISO9001, ISO14001 and OHSAS18001 Internal Auditor Certification What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!