Manufacturing Technician jobs at Upsher-Smith Laboratories - 107 jobs

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Monday - Friday 6:30AM - 3:00PM The Manufacturing Technician 1 performs fundamental tasks within a GMP environment in support of more complex manufacturing operations. The Tasks include, but are not limited to, cleaning and maintaining the work place so that it meets the standards for controlling bioburden levels; cleaning operating equipment per applicable procedures so that it meets the standards established to prevent product contamination and maintaining records/logs neatly and accurately and in accordance with current standard procedures. The technician performs job tasks in a safe manner while following specific department safety rules. PRIMARY RESPONSIBILITIES: * Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals * Detailed cleaning of equipment/facilities to MSP/cGMP standards. * Complete technical training profile as required. * Strict adherence to Dept. Safety Rules * Bulk processing and filtration involving monitoring processing parameters (i.e. pH, weights, separation, assay results..) * Perform real-time documentation during the production run. ADDITIONAL RESPONSIBILITIES English fluency both verbal and written. Basic math skills with proficiency in metric system. Accurate documentation skills are a must. Basic computer skills. Mechanical aptitude. Must be available to work any shift, including weekends. Ability to work well with others in a team environment is essential. Self-starter with the ability to work independently and use good judgment. Must be able to handle multiple priorities. Must be proactive, results oriented, and have strong attention to detail EDUCATION High school diploma or GED required. Associates Degree or Bachelor's degree preferred. Manufacturing, or experience in pharmaceuticals/biologics processing in a GMP environment is preferred. EXPERIENCE 1-2 years' experience in a manufacturing environment preferred. SKILLS & ABILITIES Accurate documentation and attention to detail oriented. Usage of a 10-key calculator. OCCUPATIONAL DEMANDS Ability to lift/push 50 lbs. All work is performed in a clean room (sanitized) manufacturing environment and must gown up. Must be able to work in a cold environment, job requires bending or standing for prolonged periods. This is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned. EEO Minorities/Females/Disability/Veterans BENEFITS * The estimated pay scale for the Manufacturing Technician I role based in Vista, CA is $21.51 - $32.26/hour depending on experience * Additionally, the position is eligible to participate in up to 5% of the company bonus pool * We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement * Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data #biomatusa Location: NORTH AMERICA : USA : CA-Vista:[[cust_building]]

Manufacturing Technician I (1st Shift) Work Schedule: Monday-Friday from 7:30am-4pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds. The Manufacturing Technician I will be responsible for conducting Good Manufacturing Practices (cGMP) manufacturing of solid oral and liquid oral pharmaceutical dosage forms for Phase I and Phase II clinical trials. Daily responsibilities will include production equipment set up, weighing of materials, sieve and blending activities, spray drying, milling, granulation, mixing, roller compaction, submitting samples, encapsulation, tableting, coating and packaging. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: Prepare materials, equipment and manufacturing suites for production Conduct GMP manufacturing of solid oral and liquid oral dosage forms Packaging and labeling of manufactured products Pre/postproduction cleaning of equipment, supplies and manufacturing area Follow Standard Operating Procedures (SOPs) and production batch records Responsible for accurate documentation in production batch records May also assist engineering with equipment validations, preventative maintenance, and cleaning verifications Other duties as assigned The Candidate: High School Diploma or GED equivalent is required One (1) year of experience is required in GMP pharmaceutical or medical device manufacturing Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently Pay: The anticipated salary range for this role in California is $40,000 to $46,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement - Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

**Manufacturing Technician (Night Shift)** 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. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturing Practices (CGMP) unit of its kind for DPI in North America. Catalent Pharma Solutions in Boston is hiring a Manufacturing Technician. The Manufacturing Technician assists in the performance of routine operations for the GMP production of pharmaceutical products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines. The Manufacturing Technician executes production activities under direct supervision for the Spray Drying of Active Pharmaceutical Ingredients. **This is a full-time, on-site, hourly role. Work schedule will be a 7-day rotating 12-hour schedule from 6:00 p.m. to 6:00 a.m. Week 1 will be 48 hours over 4 days, and week two will be 36 hours over 3 days (often referred to as a Pitman Schedule). Overtime and Holiday pay will be included.** **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:** + Performs Clean-In-Place, Clean-Out-of-Place, and equipment decontamination as required + Operates and monitors manufacturing equipment for the production of clinical and commercial pharmaceutical products + Assists in the execution of routine and complex production processes + Completes GMP documentation in legible and organized fashion + Receives and distributes supplies in the manufacturing area + All other duties as assigned **The Candidate:** + A High School Diploma or equivalent is required. Biotechnology Certificate or Associate's Degree is highly desired + Must have at least one (1) year of prior work history, preferably in a Manufacturing Environment + Working knowledge of Good Documentation and Good Manufacturing Practices preferred + Must be proficient in Microsoft Office Suite + Physical requirements: Individual may be required to sit, stand, walk regularly, use hands regularly, and occasionally lift up to 50 pounds **Pay:** + The anticipated salary range for this role in Massachusetts is $52,000 to $62,700 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Manufacturing Technician (Night Shift) 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. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturing Practices (CGMP) unit of its kind for DPI in North America. Catalent Pharma Solutions in Boston is hiring a Manufacturing Technician. The Manufacturing Technician assists in the performance of routine operations for the GMP production of pharmaceutical products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines. The Manufacturing Technician executes production activities under direct supervision for the Spray Drying of Active Pharmaceutical Ingredients. This is a full-time, on-site, hourly role. Work schedule will be a 7-day rotating 12-hour schedule from 6:00 p.m. to 6:00 a.m. Week 1 will be 48 hours over 4 days, and week two will be 36 hours over 3 days (often referred to as a Pitman Schedule). Overtime and Holiday pay will be included. 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: Performs Clean-In-Place, Clean-Out-of-Place, and equipment decontamination as required Operates and monitors manufacturing equipment for the production of clinical and commercial pharmaceutical products Assists in the execution of routine and complex production processes Completes GMP documentation in legible and organized fashion Receives and distributes supplies in the manufacturing area All other duties as assigned The Candidate: A High School Diploma or equivalent is required. Biotechnology Certificate or Associate's Degree is highly desired Must have at least one (1) year of prior work history, preferably in a Manufacturing Environment Working knowledge of Good Documentation and Good Manufacturing Practices preferred Must be proficient in Microsoft Office Suite Physical requirements: Individual may be required to sit, stand, walk regularly, use hands regularly, and occasionally lift up to 50 pounds Pay: The anticipated salary range for this role in Massachusetts is $52,000 to $62,700 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 Hours + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Company match on donations to organizations Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Manufacturing Technician - Bioprocess Join Lonza in Vacaville and be part of a dedicated team producing innovative bio-therapeutic medicines. This role offers the opportunity to work with highly automated production systems and contribute to world-class operations in a cGMP environment. What you will get: The full-time base annual salary for this position is expected to range between $43,000-$69,000. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid Time Off Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge. What you will do: Operate and maintain production systems in a cGMP environment, ensuring inspection readiness and compliance with regulatory standards. Manage inventory and process systems, maintaining accurate records and adhering to safety and environmental protocols. Participate in mammalian cell culture production across upstream (seed train, media preparation, fermentation, harvest) and/or downstream (buffer preparation, chromatography, filtration) processes. Perform dispensing of components, handle hazardous materials, and clean/sterilize equipment and fixed tank systems. Support Right-First-Time operations through detailed documentation and timely issue resolution. Utilize automation to meet production demands and collaborate effectively with team members. Contribute to continuous improvement initiatives within manufacturing operations. What we are looking for: High School Diploma or GED required; AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering preferred. Proven ability to work in a fast-paced, regulated environment. Strong attention to detail and commitment to accurate documentation practices. Ability to identify and implement solutions to process issues. Excellent collaboration and communication skills. Willingness to work a 3-4-3 shift model and adapt to changing priorities. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Join Lonza in Vacaville, CA, as a Manufacturing Technician - Bioprocess and be part of a hard-working team dedicated to producing innovative bio-therapeutic medicines. This role offers an ambitious opportunity to collaborate with highly automated production systems and contribute to our world-class operations. At Lonza, we strictly follow cGMP and SOP standards, ensuring our processes meet the highest regulatory requirements. What you will get The full-time base annual salary for this position is expected to range between $43,000 to $69,000. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus Medical, dental and vision insurance 401(k) matching plan Life insurance, as well as short-term and long-term disability insurance Employee assistance programs Paid Time Off Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge. Shift Model: 6:00a-7:00p or 6:00p-7:00a What you will do Operate and maintain production systems in a cGMP environment, ensuring inspection readiness and compliance with regulatory standards. Manage inventory and process systems, maintaining accurate records and ensuring safety and environmental protocols are followed. Participate in the production of mammalian cell culture products across various areas, including upstream (seed train, media preparation, fermentation, harvest) and/or downstream (buffer preparation, chromatography, filtration). Perform dispensing of components, handle hazardous materials, and clean/sterilize equipment and fixed tank systems. Support Right-First-Time operations with detailed documentation and timely issue resolution. Use automation for production tasks, meet production demands, and collaborate effectively with the team. What we are looking for High School Diploma or GED Required AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering preferred. Proven ability to work in a fast-paced, regulated environment. Strong attention to detail and dedication to flawless documentation practices. Ability to determine and successfully implement solutions to process issues. Excellent collaboration and communication skills. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. Ready to shape the future of life sciences? Apply now.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: Join Takeda and help deliver life-changing medicines by executing day-to-day production operations in a regulated manufacturing environment. In this hands-on role, you'll perform manual manufacturing tasks and operate automated equipment while strictly adhering to current Good Manufacturing Practices (cGMP), Environmental Health & Safety (EHS) requirements, and all applicable regulations. How you will contribute: Execute all assigned production processes and activities in the manufacturing area, including manual operations and automated equipment use. Follow cGMP, EHS guidelines, and established procedures to ensure safe, compliant, and high-quality execution. Troubleshoot straightforward process or procedure issues and escalate appropriately. Initiate minor updates to existing documents (e.g., controlled documents) with appropriate guidance. Contribute to continuous improvement efforts and participate in departmental projects and Quality Working Teams, as applicable. Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives. Support all local manufacturing operations. Complete relevant paperwork following GDP/GMP guidelines. Working in a team environment, perform hands-on execution of manual and automated manufacturing operations. Equipment includes but is not limited to: Centrifuges, Filter Presses, Ultrafiltration systems, CIP/COP, Nanofiltration Skids, Chromatography Columns and material handling devices. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, room cleaning, equipment assembly/disassembly, transfer panel connections, titrations and other activities. Receive and distribute supplies into the production area as necessary. Perform removal of hazardous waste per safety guidelines. Troubleshoot minor process problems and respond to process alarms. Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor. Participate in the training of team members on the manufacturing floor. Participate in the revision and review of pertinent documentation as appropriate. Participate in Safety and Continuous Improvement Teams. What you bring to Takeda: High school diploma or GED plus 1+ years of related experience or AA or higher with no prior experience required. General working knowledge of related manufacturing techniques and specialties. Basic Automation experience using DeltaV, Electronic Batch Management, PLC, etc. Familiarity with pharmaceutical production equipment including but not limited to centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place). Must have good communication skills in English (both verbal and written) and understanding of cGMP regulations in a pharmaceutical manufacturing environment. Must be able to read and follow detailed written procedures. Proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. Knowledge of basic chemical and biological safety procedures. Good computer skills. Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Must be able to work overtime as required, on any shift. May be required to work in a confined area. Some Clean Room and cool/hot storage conditions. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. Must be able to lift, push, pull and carry up to 50 lbs. with a work partner. Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift. Must be able to climb ladders and stairs while wearing special gowning. May require bending, twisting, reaching, and/or squatting motions to perform certain tasks. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Los Angeles U.S. Hourly Wage Range: $16.97 - $26.65 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - Los AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No

Full-time, Temporary Description At SpectraWAVE, our mission is bold yet simple: to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD) the leading cause of death worldwide. Our FDA-cleared HyperVue™ Imaging System integrates DeepOCT™, near-infrared spectroscopy (NIRS), and advanced machine learning to give interventional cardiologists real-time clarity inside the artery, where it matters most. SpectraWAVE recently received FDA 510(k) clearance for X1-FFR, an AI-enabled, wire free, drug-free, single angiogram physiology solution that delivers powerful insights without disrupting workflow. Together, HyperVue™ and X1-FFR represent a new era of precision and simplicity in coronary imaging and physiology. Backed by Johnson & Johnson Innovation - JJDC, Inc. and other leading MedTech investors, SpectraWAVE recently completed a $50M Series B funding round to accelerate commercialization and product innovation. We're a fast-growing, collaborative team united by the belief that technology can save lives. If you're inspired by innovation, energized by challenge, and ready to make a measurable impact on patient outcomes, we'd love to meet you. Job Summary We are seeking a qualified Manufacturing Technician for our medical imaging console manufacturing line. This individual will train on all aspects of hardware assembly and test, including but not limited to mechanical assembly, electronics assembly, rotator balancing, and in process and final test and inspection. This individual will be responsible for supporting daily production of our flagship opto-mechanical medical device. The right candidate will have sufficient aptitude to follow manufacturing specifications to carry out their responsibilities, become a subject matter expert on assembly, and be able to teach others to assemble. Key Responsibilities Responsible for assembly and test of the console while documenting these activities as using GMP. Responsible for maintaining Good Manufacturing Practices (GMP), such as Line Clearance, Lot Control, Cleanliness. Assist with prototype builds and testing, and documenting these activities as instructed. Maintain accurate and timely records and documentation for all assigned activities as required. Maintain work area and equipment in a clean and orderly condition and follow prescribed safety regulations. Requirements Minimum Qualifications 2 years minimum experience working in medical hardware manufacturing. Experience working in a Good Manufacturing Practices (GMP) environment. Experience working in an ESD controlled environment. Electronics assembly including circuit boards and wiring harnesses. Must be able to lift 40lbs and perform mechanical assembly of cart frame. Must be a self-starter and a fast learner. Excellent written and verbal communication skills. Communication, organizational, and critical thinking skills. Ability to track and manage multiple projects and deadlines. Results oriented. No Travel Salary Description $22/hr - $28/hr

Our client, a medical technology start up, is seeking a highly detail-oriented Manufacturing Technician to support the assembly and build of innovative medical devices in preparation for a clinical study. The ideal candidate brings prior experience assembling regulated medical devices, is comfortable working with delicate components, and thrives in an environment that prioritizes quality, consistency, and strict adherence to documented procedures. Responsibilities: Perform routine assembly and manufacturing of medical device components and subassemblies in accordance with established SOPs and work instructions Assemble fiber-based components and catheter systems to support design verification and validation testing, and ultimately clinical study preparation Prepare, clean, and stage components and materials for assembly, including careful handling of fragile parts Support final device packaging activities, including labeling and preparation for downstream testing or shipment Operate within a cleanroom environment while adhering to gowning, cleanliness, and contamination control requirements Conduct visual inspection of parts and assemblies, accurately documenting results and escalating issues in collaboration with quality team members Complete manufacturing documentation, travelers, and build records with a high degree of accuracy Identify and communicate assembly challenges, process issues, or potential quality risks to engineering and manufacturing stakeholders Maintain a safe, organized, and compliant work area Requirements: Prior hands-on experience assembling or manufacturing regulated medical devices, including involvement in at least two device products Demonstrated experience working in a cleanroom environment Excellent fine motor skills and manual dexterity Comfort using a stereoscopic microscope for assembly of small, delicate components Strong attention to detail and commitment to quality, consistency, and repeatability Ability to follow written SOPs, work instructions, and engineering documentation precisely Ability to work independently while collaborating effectively with cross-functional teams Pay $21 - $24 / hour W2, depending on experience. #INDENG

Job Title: Transformation Leader - External Manufacturing - Biologics 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. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. This is a hybrid role - 3 days a week onsite - required. 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: Support Transformation Delivery * Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. * Localize change strategies to fit the GBU context, culture, and priorities. * Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement * Ensure employees and managers understand the why, what, and how of transformation initiatives. * Develop and execute communication and training plans to maximize adoption. * Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support * Build strong relationships with GBU leaders to support them as change sponsors. * Provide coaching and guidance to managers and teams to reinforce change behaviors. * Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting * Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. * Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. * Capture lessons learned to continuously improve change implementation in the GBU. About You * Bachelor's degree in Business, Human Resources, Organizational Development, or related field. * 5+ years of experience in change management or organizational transformation. * Strong knowledge of CMO/CDMO manufacturing - Required. * Strong knowledge of change management frameworks * Demonstrated ability to work in complex, matrixed organizations. * Excellent communication, facilitation, and interpersonal skills. * Proven track record in supporting digital, operational, or organizational transformation programs. * Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy * Strategic thinking: Ability to see the "big picture" and anticipate trends * Organizational alignment: Connect transformation to business objectives Change Management * Change management: Master methodologies * Resistance management: Identify and address barriers to change * Change communication: Adapt messages to different audiences Operational Competencies * Project/Program Management * Business acumen with ability to translate transformation into operational impact. * Problem-solving and analytical thinking. * Process optimization: Identify and implement improvements * Digital literacy: Understand emerging technologies (AI, automation, cloud) * Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence * Cross-functional work: Orchestrate multi-functional teams * Inspirational leadership: Mobilize and engage teams * Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. * Emotional intelligence: Understand and manage emotions during change change * Negotiation: Find compromises and create consensus Soft Skills * Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) * Empathy: Understand the human impact of change * Resilience and adaptability in dynamic environments. 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-SG #LI-GZ #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: $147,000.00 - $212,333.33 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.

**Job Title:** Transformation Leader - External Manufacturing - Biologics **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. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. ****This is a hybrid role - 3 days a week onsite - required. **** **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:** **Support Transformation Delivery** + Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. + Localize change strategies to fit the GBU context, culture, and priorities. + Act as a key point of contact for all change-related activities in the GBU. **Drive Adoption & Engagement** + Ensure employees and managers understand the why, what, and how of transformation initiatives. + Develop and execute communication and training plans to maximize adoption. + Monitor adoption and embed new behaviors, processes, and tools into the GBU. **Stakeholder & Leadership Support** + Build strong relationships with GBU leaders to support them as change sponsors. + Provide coaching and guidance to managers and teams to reinforce change behaviors. + Act as a trusted advisor to GBU leadership on change readiness and risks. **Change Measurement & Reporting** + Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. + Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. + Capture lessons learned to continuously improve change implementation in the GBU. **About You** + Bachelor's degree in Business, Human Resources, Organizational Development, or related field. + 5+ years of experience in change management or organizational transformation. + Strong knowledge of CMO/CDMO manufacturing - Required. + Strong knowledge of change management frameworks + Demonstrated ability to work in complex, matrixed organizations. + Excellent communication, facilitation, and interpersonal skills. + Proven track record in supporting digital, operational, or organizational transformation programs. + Certification in Change Management or Project Management is a plus. **Key Competencies of a Transformation Leader** As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: **Vision & Strategy** + Strategic thinking: Ability to see the "big picture" and anticipate trends + Organizational alignment: Connect transformation to business objectives **Change Management** + Change management: Master methodologies + Resistance management: Identify and address barriers to change + Change communication: Adapt messages to different audiences **Operational Competencies** + Project/Program Management + Business acumen with ability to translate transformation into operational impact. + Problem-solving and analytical thinking. + Process optimization: Identify and implement improvements + Digital literacy: Understand emerging technologies (AI, automation, cloud) + Innovation: Promote experimentation and learning **Relational Competencies /Leadership & Influence** + **Cross-functional work: Orchestrate multi-functional teams** + Inspirational leadership: Mobilize and engage teams + Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. + Emotional intelligence: Understand and manage emotions during change change + Negotiation: Find compromises and create consensus **Soft Skills** + **Communication** : Strong communication and facilitation skills (Clarity, active listening, storytelling) + **Empathy** : Understand the human impact of change + **Resilience** and **adaptability** in dynamic environments. **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-SG \#LI-GZ \#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: $147,000.00 - $212,333.33 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 (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a "Person-in-Plant" to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: * Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) * Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's "eyes and ears" at the CMO for right-first-time execution of commercial operations. * Proactively "connect the dots" on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply * Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. * Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. * Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). * Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. * Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. * Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. * Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. * Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. * Lead continuous improvement initiatives to affect timely resolution of supply issues. * Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: * Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. * Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. * Strong technical background in aseptic manufacturing operations. * Solid project management skills and experience managing complex projects. * Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. * Strong leadership and an innate ability to collaborate and build relationships is critical. * Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change * Flexibility to work shift hours required to cover critical process steps * Ability to travel, national and international, up to 50% * Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: * Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. * Solid experience in equipment and facility qualification and validation for ATMP CMO's * Cleanroom qualification (Grade A/B) history Environment: * Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO * Must be able to remain in a stationary position 50% during cleanroom processing activities * Must be comfortable moving about inside the cleanroom to oversee process tasks * Compressed gasses and LN2 are commonly used in manufacturing operations * Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a “Person-in-Plant” to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's “eyes and ears” at the CMO for right-first-time execution of commercial operations. Proactively “connect the dots” on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. Lead continuous improvement initiatives to affect timely resolution of supply issues. Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. Strong technical background in aseptic manufacturing operations. Solid project management skills and experience managing complex projects. Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. Strong leadership and an innate ability to collaborate and build relationships is critical. Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change Flexibility to work shift hours required to cover critical process steps Ability to travel, national and international, up to 50% Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. Solid experience in equipment and facility qualification and validation for ATMP CMO's Cleanroom qualification (Grade A/B) history Environment: Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO Must be able to remain in a stationary position 50% during cleanroom processing activities Must be comfortable moving about inside the cleanroom to oversee process tasks Compressed gasses and LN2 are commonly used in manufacturing operations Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Role: Senior Manufacturing Lead Duration: 6+ Months BGV will be done for the selected candidates. 1) Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products. 2) Six Sigma certified (Black Belt) 3) Experience in CTQs assessment and translating CTQ into manufacturing specifications 4) Experience in performing gap assessments between design outputs and manufacturing specifications 5) Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality 6) Process Validation - Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) 7) Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all the influencing process parameters 8) Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV) 9) Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes 10) Good experience in Lean manufacturing. Understanding of manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. 11) Experience in Manufacturing process improvements / Manufacturing yield improvements to improve product quality 12) Good knowledge in Statistics & Minitab 13) Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA 14) Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs Six Sigma (Green belt), Medical Device, Manufacturing, Cardio-vascular, catheter, Process validation, Test Method validation, GD&T, Tolerance analysis, Jigs & Fixture design, Statistics, Minitab, Poka-Yoke, Process development, Process improvement, Value Stream mapping Mandatory Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Poka-Yoke Expert - Process improvement Good - GD&T Good - Tolerance analysis Good - Test Method validation Good - Process validation Good - Cardio-vascular catheter manufacturing process Good Desired Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Process development Good - Value Stream mapping Good - PFMEA Good - Please respond with your word resume and requested details: Full Name : Work Authorization: Contact Number : Email ID : Skype ID: Current location: Willing to relocate : Rate/hr : Additional Information All your information will be kept confidential according to EEO guidelines.

Job Title: Transformation Leader - External Manufacturing - Biologics 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. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a “local transformation enabler”: ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. **This is a hybrid role - 3 days a week onsite - required. ** 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: Support Transformation Delivery Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. Localize change strategies to fit the GBU context, culture, and priorities. Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement Ensure employees and managers understand the why, what, and how of transformation initiatives. Develop and execute communication and training plans to maximize adoption. Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support Build strong relationships with GBU leaders to support them as change sponsors. Provide coaching and guidance to managers and teams to reinforce change behaviors. Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. Capture lessons learned to continuously improve change implementation in the GBU. About You Bachelor's degree in Business, Human Resources, Organizational Development, or related field. 5+ years of experience in change management or organizational transformation. Strong knowledge of CMO/CDMO manufacturing - Required. Strong knowledge of change management frameworks Demonstrated ability to work in complex, matrixed organizations. Excellent communication, facilitation, and interpersonal skills. Proven track record in supporting digital, operational, or organizational transformation programs. Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy Strategic thinking: Ability to see the "big picture" and anticipate trends Organizational alignment: Connect transformation to business objectives Change Management Change management: Master methodologies Resistance management: Identify and address barriers to change Change communication: Adapt messages to different audiences Operational Competencies Project/Program Management Business acumen with ability to translate transformation into operational impact. Problem-solving and analytical thinking. Process optimization: Identify and implement improvements Digital literacy: Understand emerging technologies (AI, automation, cloud) Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence Cross-functional work: Orchestrate multi-functional teams Inspirational leadership: Mobilize and engage teams Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. Emotional intelligence: Understand and manage emotions during change change Negotiation: Find compromises and create consensus Soft Skills Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) Empathy: Understand the human impact of change Resilience and adaptability in dynamic environments. 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-SG #LI-GZ #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: $147,000.00 - $212,333.33 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.

GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: Performs functions associated with all manufacturing operations. Works with engineers in set-up and development of support processes. Assists in the development and execution of protocols and test runs. Design, implement and maintain production support processes. Assess manufacturing processes for compliance with written policies and procedures including QSR's and cGMP practices. Assembles and initiates documentation change order packages. Proactively communicates notifications on problems and issues. Manufacturing Engineering Technician II's at Tandem are also responsible for: Maintains, operates and develops processes in support of manufacturing operations. Performs assessments of procedures within the manufacturing environment, identifying non-conformances, recommending and implementing corrective and preventative actions. Performs all manufacturing assignments in accordance with established safety procedures and applicable regulatory requirements. Contributes to and develops equipment operating procedures (EOPs) and preventative maintenance (PMs) plans as requested. Develops and releases written and picture-based work instructions. Participates in continual process improvement activities designed to optimize quality, compliance, process efficiency, and lead times. Executes process validation and qualification protocols and documents results and findings as required. Provides training, as required, to production personnel on procedure, and process changes. Assists in the implementation Lean Manufacturing and 6 sigma techniques. Other duties as assigned. WHEN & WHERE YOU'LL WORK: Onsite: This position is fully onsite and open to candidates located in San Diego, California. Equipment for the role will be provided and training will occur onsite. Schedule: This position will work Monday - Thursday from 2:30 PM - 1:45 AM PST. WHAT YOU'LL NEED: 1. Knowledge, skills & abilities: Knowledgeable with QSRs. Must have strong cGMP documentation skills. Working knowledge of small scale electromechanical device assembly operation, Ability to effectively share information regarding issues in written or verbal form and making recommendations in a clear and concise manner. Skilled at promoting team cooperation and a commitment to team success. Demonstrated ability to effectively prioritize and handle multiple priorities and complete assignments on time and with minimal errors. Proficient with Microsoft Office and Internet. 2. Minimum certifications/educational level: Associate degree in a technical discipline, or applicable job experience and education. 3. Minimum experience: 4+ years of experience in Instrumentation or Biomedical Industries, or Consumer Electronics. Experience in FDA/GMP/ISO environment. Lean Manufacturing experience desirable. COMPENSATION: The starting base pay range for this position is $25.19 to $31.47 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. Please note that is a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based upon business need and job performance. YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time WHY YOU'LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at *************************************** BE YOU, WITH US! We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. #LI-HJ1

**About Us:** Cordis is an independent, customer-focused global provider of interventional cardiovascular medical technologies. During our 60+ year history we've established a legacy of pioneering breakthrough technologies, including the first guiding catheters and coronary drug eluting stents. Cordis has built a strong global footprint that spans over 70 countries. We're teammates, not just employees. Our culture empowers you to act like an owner and unleash your full potential in the process. With diverse teams on a global scale, we foster an inclusive atmosphere where everyone is embraced for who they are, their unique perspective, and what they bring to the table. We believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then Cordis is just the place for you. Join us, and let's improve the wellbeing of millions, together. **We are the people behind the people who keep saving lives.** The 1 st shift Sr Tech Production Set-up and Maintenance coordinates and perform the calibration and preventative maintenance activities for equipment in the Operations and R&D areas. **Responsibilities** + Perform routine calibration, preventative maintenance, and repair on manufacturing/R&D equipment and systems (including mechanical, pneumatic, and electrical systems). + Repair equipment/fixtures as requested by the equipment/fixture owner(s). + Possess basic knowledge of a wide range of equipment and the ability to provide technical support to Manufacturing, R&D, and other departments. + Ability to review results to ensure that it complies with predetermined requirements/criteria (such as visual, dimensional criteria, etc.). + Perform simple calibration activities (as required, with training). + Responsible for adhering to all hygiene and safety standards. + Responsible for following all company SOPs, cGMPs, WIs, and Quality policies. + Work with support groups to troubleshoot and repair equipment. + Must be able to work effectively with other department personnel. + Responsible for communicating business related issues or opportunities to next management level. + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. + Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets. + Performs other duties assigned as needed. **Qualifications** + High school diploma or equivalent (AA degree preferred) and 5-10years related work experiencerequired. + 5+ years working with production related equipment within a Controlled Environment Room (Clean Room) is preferred. + Experience or training in hazardous material emergency response is desirable. + Experience in a regulated industry where documentation compliance is enforced is preferred. + Knowledge of use of hand-tools. **Pay / Compensation** The expected pre-tax pay rate for this position is $27.11 - $40.67 per hour Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location. Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming. **JOIN OUR TALENT COMMUNITY** Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests. **Job Locations** _US-CA-Santa Clara_ **ID** _2025-3504_ **Category** _Operations_ **Position Type** _Regular Full-Time_ CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact *******************

Full-time Description Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data. Principal Responsibilities Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products. Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions. Assemble fragile and sensitive electro-mechanical and optical medical devices. Train manufacturing staff on assembly methods/procedures. Conduct experiments and record data in a laboratory environment; perform data analysis. Collaborate directly with engineers, production operators, quality inspectors and management personnel. Communicate technical issues clearly and effectively to engineering staff. Establish and maintain stability of late-stage development programs and build activity. Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.). Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements. Perform miscellaneous duties and projects as assigned and required. Requirements Training, Skills, Knowledge and/or Experience 3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products. Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools. General understanding of data collection, data reduction, and statistics. Experience working in FDA QSR and ISO 13485 environments preferred. Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel. Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems. Education Requirements High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required. Salary Description $22 - $32 / hour

Job DescriptionDescription: Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data. Principal Responsibilities Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products. Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions. Assemble fragile and sensitive electro-mechanical and optical medical devices. Train manufacturing staff on assembly methods/procedures. Conduct experiments and record data in a laboratory environment; perform data analysis. Collaborate directly with engineers, production operators, quality inspectors and management personnel. Communicate technical issues clearly and effectively to engineering staff. Establish and maintain stability of late-stage development programs and build activity. Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.). Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements. Perform miscellaneous duties and projects as assigned and required. Requirements: Training, Skills, Knowledge and/or Experience 3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products. Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools. General understanding of data collection, data reduction, and statistics. Experience working in FDA QSR and ISO 13485 environments preferred. Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel. Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems. Education Requirements High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required.