Manufacturing Support Technician (Bioprocess)
Manufacturing technician job at Krystal Biotech
About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK , for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated Manufacturing Support Technician to support a new state-of-the-art GMP facility in Moon Township. The Technician will work closely with the manufacturing team to uphold cleanroom standards, follow strict procedures, and contribute to the smooth operation of all manufacturing processes.
Primary Responsibilities:
Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs
Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule
Execute and maintain strict cleaning and sanitization protocols in compliance with current Good Manufacturing Practices (cGMP) guidelines and Standard Operating Procedures (SOPs)
Conduct routine inspections of cleanrooms to identify any cleanliness or contamination issues, promptly reporting and addressing them according to established procedures
Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner
Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials
Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules
Participate in training sessions and meetings to stay updated on the latest industry standards, regulations, and best practices
Assist with movement of materials; work with EHS/Materials Teams for collection and dispensing of biohazardous waste
Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends
Perform other tasks, as assigned
Requirements and Preferred Qualifications:
High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus
In lieu of direct experience, bachelor's degrees in applicable fields such as life sciences or engineering will be considered
Experience with sanitization, aseptic technique and/or sterile processes in a regulated setting (GMP, ISO) is highly preferred
Ability to follow detailed instructions and maintain accurate documentation
Excellent attention to detail, organization skills, and the ability to prioritize and multitask effectively in a fast-paced environment
Demonstrated commitment to safety protocols and adherence to standard operating procedures
Excellent communication and the ability to work well both independently and as part of a team
Physical stamina and the ability to stand, bend, and lift heavy objects when necessary
Flexibility to work shifts, including evenings, weekends, and holidays as required.
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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Maintenance & Calibration Technician
Manufacturing technician job at Krystal Biotech
Calibration/Maintenance Technician About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end to end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK , for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated Calibration & Maintenance Technician who will be responsible for the calibration and maintenance of all systems, devices and items requiring calibration at Krystal Biotech. The Technician will play a key role in the day-to-day support of the calibration, metrology, and maintenance program.
Primary Responsibilities:
Responsible for performance of routine calibration and maintenance
Operate the metrology program in adherence with site Standard Operating Procedures (SOPs)
Coordinate external services to ensure qualified resources are supporting the calibration efforts
Align calibration schedules with internal departments to ensure staff and equipment availability
Review all paperwork to ensure calibrations are documented according to the site's guidelines and SOPs
Promptly report any and all out of tolerance (OOT) findings in alignment with approved SOPs
Investigate, document and report all calibration issues in alignment with the sites Corrective Action, Preventive Action (CAPA) program
Provide support as SME for the site's building monitoring and alarm systems
Assist in the paperwork and data entry of new items needing calibration support
Experience and Skills Desired:
High School Diploma
Relevant educational training in Associate or Trade School programs preferred
Mechanical aptitude with strong troubleshooting skills and demonstrated knowledge of proper usage of power equipment, hand tools, and measurement equipment
Experience in an industrial or pharmaceutical maintenance/metrology setting preferred
Familiar with Metrology practices in a cGMP environment preferred
Must be hands-on and a self-starter
The following competencies are highly preferred, but not required:
Knowledge of metrology software systems and related equipment in a pharmaceutical setting
Prior experience with methods to verify/confirm equipment tolerances
Previous testing of biosafety cabinets, fume hoods and air balance programs
Knowledge of EH&S and OSHA practices
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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2026 Future Talent Program - Vaccine Manufacturing Automation Co-op
Point, PA jobs
The Future Talent Program features co-operative assignments that last up to 6 months and will include one or more projects. These opportunities in our Manufacturing & Supply Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
This position will report to vaccine automation management and support ongoing operational activities. Given the close interaction with actual Good Manufacturing Practice manufacturing, candidates need to be prepared to comply with Good Manufacturing Practice gowning restrictions for some of their activities (e.g. - remove jewelry, remove make-up, remove false nails, etc.).
Under the guidance of Department Management, the Vaccine Manufacturing Automation Co-op will:
Complete a variety of automation projects in support of vaccine manufacturing at the Company's West Point, PA site.
Work with computer simulation to test proposed changes before implementation in the manufacturing environment.
Author new and update existing GMP documentation.
Expect involvement with daily plant operation, including upgrades and maintenance support for manufacturing equipment and interaction with many other production support groups including technology, quality, planning, and validation.
Gain valuable understanding of Good Manufacturing Practices (GMPs), safety, environmental requirements and practical experience in equipment operation.
Required Education & Experience:
Candidates must be pursuing a degree in Engineering, Business and Engineering, or a major within the College of Computing and Informatics.
Candidates must be successful candidates will possess strong interpersonal and writing skills, with attention to detail and the ability to work independently.
Preferred Experience & Skills:
Candidates should have previous experience in the pharmaceutical industry is preferred but not required.
This is a full-time Co-Op position.
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
FTP2026
MD2026
WE2025
SHPE2025
NDiSTEM
Required Skills:
Application Maintenance, Application Maintenance, Cloud Data Catalog, Computer Science, Computer Simulations, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Hiring, Key Performance Indicators (KPI), Logistics, Manufacturing, Manufacturing Environments, Manufacturing Support, Pharmaceutical Management, Production Management, Production Support, Project Management, Python (Programming Language), Recruiting {+ 1 more}
Preferred 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”.
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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
11/3/2025
*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.
Auto-Apply2026 Future Talent Program - Vaccine Manufacturing Co-op
Point, PA jobs
The Future Talent Program features co-operative assignments that last up to 6 months and will include one or more projects. These opportunities in our Manufacturing & Supply Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
This position will report to vaccine production or engineering management and support ongoing operational activities. Given the close interaction with actual Good Manufacturing Practice manufacturing, candidates need to be prepared to comply with Good Manufacturing Practice gowning restrictions for some of their activities (e.g. remove jewelry, remove make-up, remove false nails, etc.).
This position is responsible for but not limited to:
Providing on-the-floor support of operational and technical issues; collaborating with the shop floor on a variety of different projects and activities that are critical to ongoing manufacturing of vaccines at the West Point, PA site.
Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Completing projects to improve the performance of our processes and manufacturing performance, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times.
Supporting team safety, environmental and compliance objectives.
Collaboration with the area Managers, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Supply Chain).
Executing projects and assigned studies in a right-first-time manner.
Actively using and championing the use of Lean Six Sigma (LSS) tools, both in problem solving and day-to-day operational activities.
Provide progress updates to mentor summarizing the status of the assignments that are underway.
Work with assigned mentor to develop personal and professional skills.
This is a full-time Co-Op position.
Required Education & Experience:
Candidate must be pursuing an Associates, BS, or MS degree in Chemical, Mechanical, Biomedical, or related Engineering discipline, or pursuing an Associates, BS, or MS degree in Chemistry, Biology, Biotechnology, Microbiology, Virology, or Business and Engineering.
Candidates must have communication, leadership and teamwork skills.
Preferred Experience & Skills:
Candidates should have experience in biologics, vaccine or bulk sterile manufacturing facilities.
Candidates should have experience using Lean/Six Sigma tools.
Candidates should have capabilities for managing multiple tasks simultaneously, including leading small projects.
Candidates should have experience in problem solving and/or troubleshooting.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
MD2026
FTP2026
WE25
SHPE2025
NDiSTEM
Required Skills:
Biopharmaceuticals, Deviation Investigations, Global Manufacturing, Good Manufacturing Practices (GMP), Hiring, Immunochemistry, Lean Six Sigma (LSS), Logistics, Mechatronics, Microbiology, Pharmaceutical Biology, Preventive Action, Procurement, Production Operations, Project Management Engineering
Preferred Skills:
Automation Engineering, Automation Engineering, Biology, Biomedical Engineering, Chemical Engineering, Chemistry, Collaboration Tools, Communication, Computer Networking, Cost Modeling, Cost Reduction, Creativity, Empathy, Environmental Regulatory Compliance, Equipment Maintenance, Group Problem Solving, Impact Evaluation, Leadership, Lean Manufacturing, Logistics Operations, Maintenance Management, Makeup Art, Manufacturing, Manufacturing Engineering, Mechanical Engineering {+ 14 more}
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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
11/3/2025
*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.
Auto-ApplyNDT Technician (Remote)
Pittsburgh, PA jobs
: NDT Technician Position Overview: The NDT Technician is responsible for the inspection of materials, structures, and assets by using non-destructive testing techniques to examine structures for flaws and structural weaknesses. Doing so ensures compliance with safety standards, structural integrity, and overall quality. This role involves comprehensive assessments, documentation, and reporting of findings to maintain the reliability and safety of utility pole networks. Key Responsibilities:
Inspection Protocol: Execute detailed inspections of structures and utility poles based on established safety guidelines, industry standards, and company protocols.
Structural Assessment: Evaluate the structural integrity, examining for signs of Corrosion, cracks, flaws, and other imperfections, calibration of equipment, and interpret results with respect to applicable codes, standards, and specifications.
Safety Compliance: Ensure compliance with safety regulations, identifying potential hazards and recommending necessary actions for repair or replacement.
Reporting: Accurately record inspection information into data collection application including taking pictures and attaching required information while outlining inspection results, highlighting critical issues, and providing recommendations for corrective measures.
Collaboration: Liaise with relevant stakeholders to communicate inspection outcomes and support the implementation of recommended actions.
Continuous Improvement: Contribute insights for the enhancement of inspection procedures, tools, or methodologies to optimize efficiency and accuracy.
Qualifications and Requirements:
High school diploma or equivalent; additional vocational training or experience in a related field preferred.
Minimum of one year experience with NDT, utility maintenance, or a relevant field preferred.
Knowledge: Proficient understanding of utility poles and materials, corrosion, cracks, flaws, and safety standards.
Certifications: NDT Level 2 UT, NDT Level 2 MT and NDT Level 2 PT
Preferred additional certifications: NDT Level 2 UT Shear Wave
CWI Certification preferred
Exceptional attention to detail and observational skills.
Proficiency in using inspection tools and equipment.
Strong written and verbal communication skills for report generation and collaboration.
Ability to work independently and prioritize tasks effectively.
Capable of performing fieldwork, utilizing NDT equipment.
Ability to travel a minimum of 75%.
Physical Requirements: Manual Dexterity: Fine motor skills are needed to handle tools and equipment accurately.
Good Vision: Excellent vision, including close vision, distance vision, color vision, peripheral vision, and depth perception to inspect and interpret visual indicators of flaws.
Physical Stamina: Ability to stand, walk, and bend for extended periods, often in challenging environments.
Strength and Mobility: Physical strength to lift and move equipment and materials, sometimes weighing up to 50 pounds. Agility to access confined spaces, heights, or awkward positions during inspections.
Coordination: Good hand-eye coordination to operate testing equipment effectively.
Environmental Tolerance: Capacity to work in various environments, including outdoors, at heights, or in noisy, dusty, or hazardous conditions. Mental Requirements: Attention to Detail: NDT technicians must have a keen eye for detail to detect subtle flaws and inconsistencies in materials and structures.
Analytical Skills: Ability to analyze test results and interpret data accurately is crucial for making informed decisions about the integrity of materials.
Technical Proficiency: Proficiency in using various NDT methods (e.g., ultrasonic, radiographic, magnetic particle, dye penetrant) and understanding the principles behind them.
Problem-Solving Abilities: Skills in diagnosing issues, determining the root cause of defects, and proposing solutions.
Communication Skills: Effective verbal and written communication to report findings clearly to clients, engineers, and other stakeholders.
Mathematical Skills: Basic to advanced understanding of math for calculations related to measurements and data analysis.
Learning and Adaptability: Willingness to continually learn and adapt to new technologies, methods, and industry standards. Pay Range: $32.00 - $42 / hour Note: The above job description is a general overview of the responsibilities and requirements typically associated with the role of a NDT Technician. The specific duties and requirements may vary depending on organizational requirements and industry standards. Exo is committed to equal employment opportunity. We recruit, employ, train, compensate, and promote without regard to race, religion, color, national origin, age, sex, disability, protected veteran status, or any other basis protected by applicable federal, state, or local law.
2026 Future Talent Program - Bioprocess Clinical Manufacturing & Technology - Co-Op
Point, PA jobs
The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
Our Research Scientists and Engineers are our inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology we collaborate to discover the next medical breakthrough.
We are seeking candidates for a Co-Op opportunity in our company's Vaccines and Advanced Biotechnologies Process R&D division. Specifically, this candidate would work within West Point's Biologics Pilot Plant (BPP) GMP clinical manufacturing facility. Under the direction of a project mentor, a successful candidate may work on initiatives within either the automation, process operations, or capital sub-team in the BCMT (Bioprocess Clinical Manufacturing and Technology) department.
Example Projects/Day to Day Work:
Automation: Develop code for process control, monitoring, and visualization. Develop tools to increase efficiency in the automation group and the BCMT department as a whole. Day-to-day work might include writing code, working on GMP change controls and documentation, and equipment/system testing.
Process Operations: Knowledge Management overhaul: review and clean-up SharePoint, implement playbooks for new ways of working, update templates for key deliverables. New equipment qualification support. Day-to-day work might include attending team meetings, GMP manufacturing support, equipment testing, and document generation.
Capital: Equipment specification, installation, testing, and qualification. Day-to-day work may include document generation and field execution of equipment commissioning and qualification.
The successful candidate will be expected to demonstrate the ability to convey the results of their work in both verbal and written formats. In addition to the core duties outlined above, the candidate will be expected to comply with all required training and Quality systems, collaborate across multiple functional teams, and maintain focused attention on safety for themselves and their team.
Education Minimum Requirement:
Candidates must be enrolled in a minimum of a BS/BA in: Engineering, Computer Science, Data Science, Chemistry, Biology, or other relevant discipline.
Required Experience and Skills:
Must have the ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Must have ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Effective organization, interpersonal, verbal and written communication skills.
Candidates must be available to work full-time for 4-6 months.
Preferred Experience and Skills by Group:
Automation: Programming experience especially python and/or process control (PLC, DeltaV, etc.). Previous GMP, manufacturing, and/or equipment experience. A drive to self-learn technologies with initial guidance.
Process Operations: Proven ability to work in hands-on laboratory or manufacturing setting. Direct experience with cell culture/fermentation and/or downstream purification operations of large molecules (vaccines or biologics).
Capital: Previous GMP, manufacturing, and/or equipment experience. Engineering degree preferred.
To learn more about the PRD team, click: Join Our Process Research & Development Team
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
FTP2026
RL2026
PRD
Required Skills:
Preferred 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”.
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:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/3/2025
*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.
Auto-ApplyTechnician Manufacturing (Cleanroom Packaging) 1st shift- Exton, PA
Exton, PA jobs
Technician Manufacturing (Cleanroom Packaging), 1st shift Exton, PA Monday - Friday, 6:00am - 2:30pm As a Manufacturing Technician in Packaging, you will assure that dsm-firmenich products are of consistent and high quality by producing products in compliance with established DSM/GMP procedures. It is helpful if you can work with small parts and tie knots for our mechanical devices.
dsm-firmenich Biomedical is the world's unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare. For more than 30 years, the company has been at the forefront of biomaterial science and process innovation, and the leading resource for global medical device and pharmaceutical companies.
Your key responsibilities
* Assists with performing designated operations within their manufacturing department, non-controlled and controlled environment areas in accordance with dsm-firmenich Standard Operation Procedures and all safety requirements as assigned.
* Handling of chemicals and solvents may be required.
* Provides basic support to outside own department as required.
* Provides suggestions on potential improvement opportunities in quality, product, processes and efficiency.
* Addresses simple and recognizable problems, from past experiences, and chooses from established alternative approaches to find a solution.
* Works with R&D, Engineering and other dsm-firmenich groups as assigned.
* Expresses ideas and listens to ideas of others.
* Seeks opportunities and sets goals for own development. Identifies and learns from mentors/developmental advisors. Keeps appropriate people informed.
* Works within job/position specific deadlines and schedules set by production schedule/supervisor. Keep detailed, accurate, and legible paper and computerized records of production activities following dsm-firmenich/GMP guidelines.
* Advise Group Lead/and/or Supervisor of perceived problems with processes, machinery, or product quality. Perform other duties as assigned by Manufacturing Supervisor.
* Assure product quality through close attention to detail, inspection methods, and in-process testing as required.
We offer
* Paid holiday, 18 days PTO + 2 floating holidays
* Full healthcare benefits day one - medical, dental, eye, and life insurance.
* 401K with generous company match
* Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
* A chance to impact millions of consumers every day - sustainability embedded in all we do
* A science led company, cutting edge research and creativity everywhere -from biotech breakthroughs to sustainability game-changers, you'll work on what's next
* Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership
* A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on
* A community where your voice matters - it is essential to serve our customers well.
You bring
* High School Diploma/GED. Two-year technical degree preferred or equivalent years of experience in related fields.
* 0-5 years' experience, preferably in Medical Device manufacturing or GMP related industry.
* Packaging experience, preferably in medical device manufacturing or related industry.
* Strong oral and written communication skills to provide information to others by telephone, in written form, email, or in person. Interpersonal skills to interact and communicate effectively with all levels of personnel.
* Proficient in the use of M/S Office, Word, and Excel.
* Ability to operate various equipment and hand tool in assigned areas with limited supervision.
* Industrial scale hands-on experience with process optimization focus. Ability to identify process improvement opportunities and present them.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Hourly $23.00 USD.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
Technician Manufacturing (Mechanical Device) 2nd shift-Exton, PA
Exton, PA jobs
Technician Manufacturing, (Mechanical Device) 2nd shift Exton, PA (USA) Onsite (Monday - Friday 2:00 PM - 10:30 PM) As a Manufacturing Technician in Mechanical Device, you will assure that dsm-firmenich products are of consistent and high quality by producing products in compliance with established DSM/GMP procedures. It is helpful if you can work with small parts and tie knots for our mechanical devices. dsm-firmenich Biomedical is the world's unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare.
Responsibilities:
* Assists with performing designated operations within the manufacturing department, non-controlled and controlled environment in accordance with dsm-firmenich Standard Operation Procedures and all safety requirements as assigned.
* Handling of chemicals and solvents may be required.
* Provide basic support to outside own department as needed.
* Provides suggestions on potential improvement opportunities in quality, product, processes and efficiency.
* Addresses simple and recognizable problems, from past experiences, and chooses from established alternative approaches to find a solution.
We bring:
* Paid holidays, 18 days PTO + 2 floating holidays.
* Full healthcare benefits day one - medical, dental, eye and life insurance.
* 401K with generous company match.
* A competitive compensation package, with comprehensive health and welfare benefits.
* A place to grow and develop.
* A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
* The opportunity to work on growing brands and build on a strong foundation.
* The chance to make improvements and make an impact on the business.
You bring:
* High School Diploma/GED. wo-year technical degree preferred or equivalent years of experience in related fields.
* 0-5 years' experience, preferably in Medical Device manufacturing or GMP related industry.
* Ability to work with small parts and tie knots.
* Strong oral and written communication skills.
* Proficient in the use of M/S Office, Word, and Excel.
* Knowledge and experience working with machinery, tooling, and products/processes in a medical device environment preferred.
* Industrial scale hands-on experience with process optimization focus.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Hourly $23.00 + $1.25/hour 2nd shift differntial USD.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
Manufacturing Technician
Exton, PA jobs
Title: Manufacturing Technician Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
Responsible for maintaining GMP Cleanrooms, equipment, performing manufacturing procedures and executing diverse tasks in various clinical trial material processing areas. Follows cGMP requirements as well as policies and procedures of the business.
The ideal candidate will have working experience in a regulated pharma or biotech environment (GMP, SOPs, Cleanroom and Equipment Maintenance etc.).
Position Responsibilities:
* Participate in cleaning and set up of equipment and clean/disinfect cleanrooms rooms as necessary. Monitor and record readings of equipment and systems.
* Executes and monitors manufacturing processes according to operational procedures.
* Verifies parameters to ensure CGMP and GLP compliance.
* Takes samples and performs tests during process according to standard procedures.
* Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
* Troubleshoots equipment issues. Performs equipment maintenance, conditioning, standardization, and calibration as needed.
* Handles, stores, and disposes of hazardous and nonhazardous materials incompliance with company policy and regulatory requirements.
* Handles chemicals appropriately using required safety equipment. Participates in the execution of validation/revalidation protocols.
* Individuals with sterile work environment, buffer formulation, aseptic cleanroom operations experience is a preference.
* Candidates will also be required to gown up, so they need to be screened for their comfort with gowning.
* Perform tasks assigned by his/her manager per procedures and practices compliant with cGMP.
* Perform moderate to high complexity pharmaceutical processing and testing procedures.
* Meet the quality and quantity production and testing goals established by the department and appropriately manage any exceptions.
Educational Background/ Experience
* High School Diploma, Technical, or Associate degrees is required.
* 1+ years of experience in the pharma, chemical, biotech industry or related field
* Must be able to read, understand, and follow the company's SOP's, policies and practices.
* Ability to perform physical duties including lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
* Potential exposure to particulates, vapors or noisy environment. Must be able to wear a Respirator or Dust Mask.
* Experience with cGMP guidelines.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Manufacturing Technician
Exton, PA jobs
Job Description
Manufacturing Technician
Title: Manufacturing Technician
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
Responsible for maintaining GMP Cleanrooms, equipment, performing manufacturing procedures and executing diverse tasks in various clinical trial material processing areas. Follows cGMP requirements as well as policies and procedures of the business.
The ideal candidate will have working experience in a regulated pharma or biotech environment (GMP, SOPs, Cleanroom and Equipment Maintenance etc.).
Position Responsibilities:
Participate in cleaning and set up of equipment and clean/disinfect cleanrooms rooms as necessary. Monitor and record readings of equipment and systems.
Executes and monitors manufacturing processes according to operational procedures.
Verifies parameters to ensure CGMP and GLP compliance.
Takes samples and performs tests during process according to standard procedures.
Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
Troubleshoots equipment issues. Performs equipment maintenance, conditioning, standardization, and calibration as needed.
Handles, stores, and disposes of hazardous and nonhazardous materials incompliance with company policy and regulatory requirements.
Handles chemicals appropriately using required safety equipment. Participates in the execution of validation/revalidation protocols.
Individuals with sterile work environment, buffer formulation, aseptic cleanroom operations experience is a preference.
Candidates will also be required to gown up, so they need to be screened for their comfort with gowning.
Perform tasks assigned by his/her manager per procedures and practices compliant with cGMP.
Perform moderate to high complexity pharmaceutical processing and testing procedures.
Meet the quality and quantity production and testing goals established by the department and appropriately manage any exceptions.
Educational Background/ Experience
High School Diploma, Technical, or Associate degrees is required.
1+ years of experience in the pharma, chemical, biotech industry or related field
Must be able to read, understand, and follow the company's SOP's, policies and practices.
Ability to perform physical duties including lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
Potential exposure to particulates, vapors or noisy environment. Must be able to wear a Respirator or Dust Mask.
Experience with cGMP guidelines.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
.
Manufacturing Technician
Exton, PA jobs
Manufacturing Technician
Title: Manufacturing Technician
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
Responsible for maintaining GMP Cleanrooms, equipment, performing manufacturing procedures and executing diverse tasks in various clinical trial material processing areas. Follows cGMP requirements as well as policies and procedures of the business.
The ideal candidate will have working experience in a regulated pharma or biotech environment (GMP, SOPs, Cleanroom and Equipment Maintenance etc.).
Position Responsibilities:
Participate in cleaning and set up of equipment and clean/disinfect cleanrooms rooms as necessary. Monitor and record readings of equipment and systems.
Executes and monitors manufacturing processes according to operational procedures.
Verifies parameters to ensure CGMP and GLP compliance.
Takes samples and performs tests during process according to standard procedures.
Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
Troubleshoots equipment issues. Performs equipment maintenance, conditioning, standardization, and calibration as needed.
Handles, stores, and disposes of hazardous and nonhazardous materials incompliance with company policy and regulatory requirements.
Handles chemicals appropriately using required safety equipment. Participates in the execution of validation/revalidation protocols.
Individuals with sterile work environment, buffer formulation, aseptic cleanroom operations experience is a preference.
Candidates will also be required to gown up, so they need to be screened for their comfort with gowning.
Perform tasks assigned by his/her manager per procedures and practices compliant with cGMP.
Perform moderate to high complexity pharmaceutical processing and testing procedures.
Meet the quality and quantity production and testing goals established by the department and appropriately manage any exceptions.
Educational Background/ Experience
High School Diploma, Technical, or Associate degrees is required.
1+ years of experience in the pharma, chemical, biotech industry or related field
Must be able to read, understand, and follow the company's SOP's, policies and practices.
Ability to perform physical duties including lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
Potential exposure to particulates, vapors or noisy environment. Must be able to wear a Respirator or Dust Mask.
Experience with cGMP guidelines.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
.
Auto-ApplyProduction Operator- Vaccines
Pennsylvania jobs
Job Title: Production Operator- Vaccines
About the Job
Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
Performs production in accordance with volume fluctuation, business need, and effective procedures. Responsible for Manufacturing actives in assigned area. Performs production in accordance with volume fluctuation, business need, and effective procedures.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Safety:
Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings.
Reports all safety issues, concerns, incidents and near misses to the team leadership.
Actively participates in safety walkthroughs coordinated by the department's safety team.
Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.
Follows effective procedures to ensure the production of a safe and efficacious product.
Utilizes +QDCI boards for Safety issues
Attends Safety Meetings.
Quality:
FDA audit understanding and awareness. Ensures process in areas is following proper procedures at all times
Identifies possible deviation occurrences and prevents or aids in investigations and root cause analysis.
Ensures completion of quality documentation (BFR's, logbooks, etc) accurately in a timely manner.
Understands the function of the quality group and works with them to maintain a positive rapport.
Maintains acceptable execution with no emerging negative trends in procedural deviations
Delivery:
Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs
Completes tasks and corresponding documentation as required by cGMP to ensure document completion.
Works to prepare assigned areas for the oncoming shifts to ensure continuous operation.
Must ensure maintenance of gowning and Physical dexterity to complete proper set up of machines so not to impact the safety, quality, and integrity of the product.
All other duties as assigned. Adheres to all other company time keeping and attendance policies.
Ensures all Final Container materials required for production are available prior to need. These materials must be ready for aseptic filling operations to ensure the safety, quality, purity, and integrity of the product is maintained.
Ensures the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.
Cost:
Executes procedure as documented to avoid deviations.
Responsibly uses material in an efficient manner to reduce waste.
Utilizes Filling Standards to capture and Record HRxHR and Change Over Activities.
Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.
Involvement:
Trains and orients new team members (at any level) as assigned.
Follows proper documentation as required by cGMP.
Has a thorough working knowledge of cGMP's and works to help others understand.
In on time and attends and participates in Shift Change.
Maintains acceptable training as described in key requirements.
All other duties as assigned.
Context of the job/major challenges
Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.
Works with Senior Technicians, leads, and managers to ensure operational area is running as intended to meet all operational goals.
Must attend shift change daily to ensure preparedness for work day.
Completes Real Time SAP transactions on all aspects of Inventory Management.
Obtains and Maintains access to necessary systems as needed (SAP, RT Reports , eDoc, HMI, SCADA access, Virtual Standards, etc.).
Reports production issues and observations and relays to leadership team.
Understands science behind process steps and technology including aseptic processing.
Works to prepare area for oncoming shifts.
Is trained to complete Environmental Monitoring sampling and corresponding documentation.
Works with lead technicians and managers to ensure continuous operation.
Maintains aseptic work environment.
Must be able to train and work in multiple production areas in the Filling umbrella including material movement, prep, and the aseptic corridor.
Must ensure training and gowning status is acceptable all time to ensure agility to work in aseptic production areas.
Must be able to complete training in all areas as required this includes aseptic filling and machine operation.
Dimensions/Scope
This role is for a nonexempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.
Their responsibilities are, but are not limited to:
About You
Requirements
Certifications and Education/experience
Requires good mechanical skills, computer skills and is detail oriented. Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.
Prior or related cGMP or Pharmaceutical experience recommended
HS diploma or equiv and 3+ years in cGMP or Pharmaceutical experience
Associates with 2 + yrs in cGMP or Pharmaceutical experience
Bachelors with 1 + yrs in cGMP or Pharmaceutical experience
Proficiency in at least but not limited to three areas of operations or product line.
Must be a qualified trainer in one or more areas. Must be proficient in at least one of the following areas: BFR review, Environmental monitoring, Utliliy Sampling, Documentation Coordinator, logbook review, technical writing (SWI revisions).
Must have knowledge and access to systems (SAP, Trackwise, Master , EMS, PMS, SCADA, RT Reports, Labware).
Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI)
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$19.63 - $26.18
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplyRMF Production Technician - Vaccines
Pennsylvania jobs
Job Title: RMF Production Technician - Vaccines
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as a Production Technician - Vaccine within our Biologics Team, will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Note:
This is a 3rd shift position. Must be able to work weekends and holidays as needed.
This position is to become part of the Production team to support the engineering, construction, qualification, validation, and licensure of the B55 Recombinant Manufacturing Facility. This position contributes as a member of a cross-functional team to support the startup of the cGMP manufacturing facility for Flublok /Panblok drug substance in Swiftwater PA and will later continue to support the cGMP commercial. manufacturing of drug substances requiring a high degree of relationship building, communication, technical knowledge, and leadership.
Sanofi is seeking a motivated professional candidate to operate within Biologics production and perform manufacturing activities. This is an exciting opportunity for a candidate to develop technical skills and learn about the biopharmaceutical industry. The production technician will operate in a cGMP manufacturing area performing equipment set up and operations tasks to meet all standards for safety, quality, and efficiency. The candidate will perform production in accordance with volume fluctuation, business need, and effective procedures.
This position may be required to be moved or temporarily flexed to another department or building within the Biologics operations due to business needs. Additionally, candidates should expect to work in multiple buildings. Some overtime/off shift work hours may be required based on business needs.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Ensuring that processes are always compliant with FDA regulations.
Works to become trained in all assigned training modules.
Identifying and preventing deviations and assisting in investigation and root cause analysis.
Helping with deviation investigations, Corrective and Preventive Actions (CAPA), Change Control Requests (CCR), and other assigned projects.
Ensuring that quality documents like Electronic Batch Records (eBRs) and electronic logbooks are completed accurately and on time.
Ensuring documentation is completed accurately and in real-time is crucial for compliance and quality control.
Preparing areas for the next shift helping to maintain smooth operations and efficiency.
Responsibly use material in an efficient matter to reduce waste.
Sharing improvement ideas, issues, concerns to team members along with providing solutions.
Proactive in identifying and solving production issues to ensure smooth operations.
Follow all procedures put into effect to ensure your safety as well as the safety of others. Participate in monthly safety meetings.
Report all safety issues, concerns, incidents, and near misses to the team leadership promptly.
Actively participate in safety walkthroughs coordinated by the department's safety team.
Provide input on potential safety issues and contribute ideas for the corrective and preventative actions.
About You:
Required Qualifications
High School Diploma plus one-year experience in a cGMP environment or pharmaceutical experience.
Associate Degree and Bachelor's degree with 0-year experience.
Good mechanical skills, computer skills and is detail oriented.
Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.
Proficiency in at least but not limited to one area of operation or product line.
Special Working Conditions
Ability to lift up to 50 lbs.
Ability to stand on average 8 hours per shift.
Ability to gown and gain entry to manufacturing areas.
Ability to be flexible with work schedule. Potentially modified shifts for training and business needs including holidays and weekend
May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need.
May also include working in an aseptic processing area.
Fit testing requirements of N95 may be required depending on the area you are assigned
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$19.63 - $26.18
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplyPackaging Technician
Philadelphia, PA jobs
(2nd shift) Catalent Pharma Solutions in Philadelphia, PA is hiring a Packaging Technician (2nd shift) in the Operations Department. The Operations Department is responsible for providing customized innovative manufacturing and packaging solutions. The department oversees all manufacturing and production aspects of quality packaging and labeling of our customer's clinical trial projects.
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 hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
This position must be able to work in a team environment to offer quality packaging and labeling of customer's clinical trials. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time
This is a full-time hourly position: Monday - Friday,4:00pm to 12:10am.
Please Note: Occasional weekend work is required. This is a union position.
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:
* Inspect blister cavities, bottles, pouches, vials, ampoules, syringes, and sealed clinical cards for defects such as missing product, poor seals, misaligned closures, print errors, or contamination.
* Perform hand counts of product using trays and fill tablet, bottle, desiccant, and closure hoppers.
* Support manufacturing tasks including de-inking product, tablet breaking, oversized capsule filling, and capsule inspection.
* Place blister units into assigned card locations for multi-fill operations, following product assignment requirements on look-alike or multi-fill projects.
* Inspect and verify clinical labels, ensuring 100% accountability for both manual and automated applications.
* Operate barcode scanners and computers for packaging and assembly work.
* Perform cleaning of product contact parts, machine equipment, and production rooms according to SOPs and logbook requirements.
* Execute sanitation tasks using the three-bucket mop system for ceilings, walls, and floors.
* Work in cold storage environments as required, handling products both inside and outside refrigerated conditions.
* Adhere to all SOPs, safety, and quality requirements while ensuring accuracy and compliance in all packaging operations.
* Other duties as assigned.
The Candidate:
* High School Diploma or equivalent.
* 2-3 years previous production or warehouse experience preferred.
* Ability to read and interpret customer specifications, cGMPs, SOPs, and follow written/oral instructions accurately while communicating effectively.
* Demonstrates attentiveness, professionalism, good personal hygiene, and strong teamwork skills in a fast-paced environment.
* Able to troubleshoot problems, report issues, and follow all plant safety guidelines.
* Physically capable of standing, walking, sitting, and occasionally lifting up to 25 lbs; must meet vision requirements for reading documents and computer use.
* Willingness to work overtime, frequently in cold environments, and perform sanitation/cleaning tasks (e.g., mopping walls, floors, ceilings, equipment).
* Accessible to both manufacturing floor and office staff, with ability to operate required office equipment.
Position Benefits:
* Diverse, inclusive culture
* Several Employee Resource Groups focusing on D&I
* Dynamic, fast-paced work environment
* 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
* Competitive salary
* Community engagement and green initiatives
* Medical, dental and vision benefits effective after 90-day probationary period
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.
Auto-ApplyPackaging Technician
Philadelphia, PA jobs
**(2nd shift)** Catalent Pharma Solutions in Philadelphia, PA is hiring a **Packaging Technician (2nd shift)** in the Operations Department. The Operations Department is responsible for providing customized innovative manufacturing and packaging solutions. The department oversees all manufacturing and production aspects of quality packaging and labeling of our customer's clinical trial projects.
_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 hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
This position must be able to work in a team environment to offer quality packaging and labeling of customer's clinical trials. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time
**This is a full-time hourly position: Monday - Friday,4:00pm to 12:10am.**
**Please Note: Occasional weekend work is required. This is a union position.**
**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:**
+ Inspect blister cavities, bottles, pouches, vials, ampoules, syringes, and sealed clinical cards for defects such as missing product, poor seals, misaligned closures, print errors, or contamination.
+ Perform hand counts of product using trays and fill tablet, bottle, desiccant, and closure hoppers.
+ Support manufacturing tasks including de-inking product, tablet breaking, oversized capsule filling, and capsule inspection.
+ Place blister units into assigned card locations for multi-fill operations, following product assignment requirements on look-alike or multi-fill projects.
+ Inspect and verify clinical labels, ensuring 100% accountability for both manual and automated applications.
+ Operate barcode scanners and computers for packaging and assembly work.
+ Perform cleaning of product contact parts, machine equipment, and production rooms according to SOPs and logbook requirements.
+ Execute sanitation tasks using the three-bucket mop system for ceilings, walls, and floors.
+ Work in cold storage environments as required, handling products both inside and outside refrigerated conditions.
+ Adhere to all SOPs, safety, and quality requirements while ensuring accuracy and compliance in all packaging operations.
+ Other duties as assigned.
**The Candidate:**
+ High School Diploma or equivalent.
+ 2-3 years previous production or warehouse experience preferred.
+ Ability to read and interpret customer specifications, cGMPs, SOPs, and follow written/oral instructions accurately while communicating effectively.
+ Demonstrates attentiveness, professionalism, good personal hygiene, and strong teamwork skills in a fast-paced environment.
+ Able to troubleshoot problems, report issues, and follow all plant safety guidelines.
+ Physically capable of standing, walking, sitting, and occasionally lifting up to 25 lbs; must meet vision requirements for reading documents and computer use.
+ Willingness to work overtime, frequently in cold environments, and perform sanitation/cleaning tasks (e.g., mopping walls, floors, ceilings, equipment).
+ Accessible to both manufacturing floor and office staff, with ability to operate required office equipment.
**Position Benefits:**
+ Diverse, inclusive culture
+ Several Employee Resource Groups focusing on D&I
+ Dynamic, fast-paced work environment
+ 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
+ Competitive salary
+ Community engagement and green initiatives
+ Medical, dental and vision benefits effective after 90-day probationary period
**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 (*************************************************************************************************************************** .
Supervisor Manufacturing
Exton, PA jobs
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Auto-ApplySupervisor Manufacturing
Exton, PA jobs
Job Description
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Senior Manufacturing Technician
Exton, PA jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Sr. Manufacturing Technician will be responsible for the performance of all critical biologics manufacturing steps per production scheduling, material staging, equipment set-up, and GMP operations in the Biologics Operations group. The Sr. Manufacturing Technician will operate biopharmaceutical equipment used to manufacture buffer/media, clean/sterilize manufacturing materials, monitor the process performance, assist troubleshooting, and adhere to GMP documentation ensuring compliance to relevant regulations. The Sr. Manufacturing Technician is a strong team player and builds connections within team to achieve goals and solve problems.Essential Functions:
Provide hands-on support and/or some leadership in the operation of equipment to support commercial manufacturing. Demonstrate initiative and ownership in achieving high-quality output on time.
Coordinate equipment maintenance, calibration, and validation with appropriate internal departments. Troubleshoot equipment as necessary during production operations.
Perform review and revision of SOPs and master batch record instructions to improve operational accuracy and efficiency.
Execute SAP transactions in a commercial environment.
Support in troubleshooting product and equipment issues and deviations. Lead / assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions. Participate in root-cause analysis and CAPA activities.
Interact cross-functionally with Upstream/Downstream Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaigns. Communicate effectively across levels and influence for best outcomes.
Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines. Apply a process-centric approach and demonstrate flexibility toward continuous improvement initiatives.
Requirements:
High School Diploma or equivalent with 3+ years relevant experience in a specific area in biopharmaceutical/ pharmaceutical manufacturing operations OR a combination of equivalent education and work experience.
Previous experience with GMP commercial product manufacturing of pharmaceutical products. Specific knowledge in buffer/media preparation, autoclaving, and/or raw material sampling is a plus.
End-User experience and/or knowledge in SAP Process systems as used in a regulated manufacturing environment (not IT SAP role).
Ability to identify, investigate, and resolve basic process and equipment problems.
Strong working knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
Ability for weekend rotation and few long process days.
Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Biologics Operations.
Self-starter with a strong focus on detail, safety, quality and results. Demonstrates grit and persistence in overcoming obstacles.
Strong written and verbal communication skills. Presents information clearly and tailored to the audience.
#LI - SC1
#LI - VF
Eisai Salary Transparency Language:
The hourly rate for the Senior Manufacturing Technician is from :$33-$43Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyTechnology Co-op with Drexel University: Spring/Summer A-Round
Philadelphia, PA jobs
Susquehanna is a global quantitative trading firm founded with an entrepreneurial mindset and a rigorous analytical approach to decision making. We commit our own capital to trade financial products around the world.
With experts in almost every discipline, we build some of the most powerful trading systems in the financial industry. By integrating sophisticated coding techniques with innovative engineering ideas, we design and optimize systems that can process massive amounts of data while still ensuring high performance and stability. Working with traders and quants, our systems engineers, network architects, technical analysts and software developers create industry-leading technical solutions.
Our nearly 800 technologists are quick-thinking, open-minded, able to execute on ideas, and committed to innovation. We use an iterative and agile approach, testing and improving our ideas along the way. Our engineers and developers focus on the entire technology stack, always with an eye towards evolving a stable, scalable, optimized technology environment with minimized risk.
Susquehanna's co-op students directly impact day-to-day projects in our technology teams. The Susquehanna Co-op Program gives you an opportunity to apply what you learn in class to real world scenarios. We offer co-op classes at Susquehanna designed to further familiarize you with our business, the markets, and the different entities that operate under the Susquehanna umbrella.
What we're looking for
Computer Science, Information Technology, Engineering, Math, Physics or other technical major preferred
Minimum GPA of 3.0
Strong communication skills; ability to interact effectively with all levels of the organization
Must be a self starter, a quick learner, and resourceful in solving problems
Ability to work as part of a team while having the confidence to act autonomously
Attention to detail; ability to handle multiple tasks in a fast-paced environment
Knowledge of technologies related to specific technical domain (including but not limited to: C++, C#, Python, .Net, Java, scripting languages, Oracle, SQL server, Windows/Linux operating systems, TCP/IP routers, switches, networking and security technologies, firewalls)
Experience in the financial services industry or completion of finance/investment related coursework a plus
What's in it for you
Relaxed dress code (jeans and sneakers are the norm and team jerseys every Friday)
Co-op classes designed to teach about Susquehanna's business and encourage professional development
Fully stocked kitchens for breakfast, lunch, snacks, and beverages
A forty thousand square-foot state of the art fitness facility with brand-new equipment, multi-purpose courts, group exercise classes, and locker room spaces
Discounts for dining, entertainment, shopping, travel, and attractions
Social events such as a poker tournament, holiday party, company outings, and more
On-site Wellness Center
On-site services such as a mailroom, barber, dry cleaning, and car maintenance
Opportunities to give back to the community through Susquehanna sponsored events and donation drives
About Susquehanna
Susquehanna is a global quantitative trading firm powered by scientific rigor, curiosity, and innovation. Our culture is intellectually driven and highly collaborative, bringing together researchers, engineers, and traders to design and deploy impactful strategies in our systematic trading environment. To meet the unique challenges of global markets, Susquehanna applies machine learning and advanced quantitative research to vast datasets in order to uncover actionable insights and build effective strategies. By uniting deep market expertise with cutting-edge technology, we excel in solving complex problems and pushing boundaries together.
If you're a recruiting agency and want to partner with us, please reach out to ******************. Any resume or referral submitted in the absence of a signed agreement will not be eligible for an agency fee.
Auto-ApplyPHL_Engineering Technician
Philadelphia, PA jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
All activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and participation of teams, tracking and analysis metrics, a basic understanding and utilization of good engineering practices, and the use of Lean Six Sigma techniques. Additional responsibilities include supporting the Business Units and plant Operations with serialization tasks and systems.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ For assigned equipment projects, take the primary responsibility for the installation, setup and testing of packaging equipment including but not limited to the following:
+ Moving and placing equipment
+ Connecting mechanically and/or electrically
+ Setting and Testing equipment
+ Building programs/recipes
+ Vendor management
+ Cross functional collaboration
+ Customer interaction
+ Equipment Safety
+ Equipment Reliability
+ Equipment Performance
+ Lead the field activities for Process Line Trials (PLT's) and Engineering trials of packaging equipment related topics.
+ Mechanical equipment
+ Electrical equipment
+ Control instrumentation
+ Troubleshooting
+ Provide expertise and training to the Mechanical team for packaging equipment related topics as the equipment Subject Matter Expert (SME)
+ Conducts and/or participates in customer meetings and attends occasional off-site meetings. Interacts with Sales and customers to determine requirements for new products/orders.
+ Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
+ Prepares Standard Operating Procedures (SOPs), line layouts, production line diagrams as needed.
+ Assist with Factory & Site Acceptance Testing (FAT/SAT) for all assigned projects.
+ Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria.
+ Responsible for determining Operational Qualification (OQ) parameters to start validation.
+ Coordination of outside design, integration, and equipment manufacturing services.
+ Assist Validation with OQ and Process Qualifications (PQ) of new packaging business.
+ Write and modify SOPs relating to the production area and assist in training of affected personnel.
+ Assists with Corrective And Preventative Actions (CAPA) investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.
+ Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation.
+ Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.
+ Creates and modifies Antares recipes for products run on lines with Antares Tracking System.
+ Maintains and operates the Antares Warehouse Tracking System (WTS) process.
SUPERVISORY RESPONSIBILITIES:
+ No supervisory responsibilities.
**Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Office and Production floor environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ Associate or technical degree in mechanical science, electrical science or instrumentation control, or minimum of 5-8 years of experience with automated packaging equipment.
+ Minimum of 3 years of relevant experience in a Lean and/or Six Sigma environment.
+ Minimum of 5-8 years of relevant experience with packaging equipment.
+ Lean Six Sigma Background preferred.
+ Pharmaceutical and/or food packaging background preferred.
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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled