Chesterfield, MO · On-site
... analyses, risk analyses, etc. * Participate on design control teams to author and/or review ... Drive testing activities, protocols, work instructions, lab notebooks, and technical reports for ...
Chesterfield, MO · On-site
... analyses, risk analyses, etc. * Participate on design control teams to author and/or review ... Drive testing activities, protocols, work instructions, lab notebooks, and technical reports for ...
Saint Louis, MO · On-site
... analyses, risk analyses, etc. * Participate on design control teams to author and/or review ... Drive testing activities, protocols, work instructions, lab notebooks, and technical reports for ...
Saint Louis, MO · On-site
... analyses, risk analyses, etc. * Participate on design control teams to author and/or review ... Drive testing activities, protocols, work instructions, lab notebooks, and technical reports for ...
ROLE SUMMARY This role will support a wide variety of analytical lab, pilot plant, process and ... Pfizer compensation structures and benefit packages are aligned based on the location of hire. The ...
ROLE SUMMARY This role will support a wide variety of analytical lab, pilot plant, process and ... Pfizer compensation structures and benefit packages are aligned based on the location of hire. The ...
Groton, CT · On-site
ROLE SUMMARY This role will support a wide variety of analytical lab, pilot plant, process and ... Pfizer compensation structures and benefit packages are aligned based on the location of hire. The ...
Groton, CT · On-site
ROLE SUMMARY This role will support a wide variety of analytical lab, pilot plant, process and ... Pfizer compensation structures and benefit packages are aligned based on the location of hire. The ...
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Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 29 days ago
8.3
Based on 122 frontline employees who took The Breakroom Quiz
23rd of 71 rated pharmaceutical
About the Role
We are seeking an accomplished and forward-thinking engineer to join our Biotherapeutics Pharmaceutical Research & Development - Drug Product Design & Development (DPDD) organization. In this highly visible role, you will support the selection, qualification and implementation of components and container closure systems for early and late stage projects, as well as, participate in applicable design verification activities for design control projects that support the development and use of certain prefilled syringe (PFS), co-packaged and cross labeled combination products, while championing quality, compliance, and continuous improvement.
This role offers the opportunity to influence strategy, drive operational excellence, and play a critical part in advancing products from development through commercialization-ultimately impacting patients' lives worldwide.
What You'll Do
Work closely with vendors, research and development SMEs and commercial Site SME's in the evaluation, development, qualification and implementation of new components and container closure systems
Support the formulation and process development groups in Andover and St Louis sites to comply with regulatory requirements and guidance documents related to components and container closure systems
Author and/or review engineering and development documentation such as component drawings and specifications, assembly drawings, tolerance stack analyses, risk analyses, etc.
Participate on design control teams to author and/or review applicable design control documentation, such as design verification supporting documentation, specifications, component/device requirements and related functionality assessments, risk assessments, etc..
Facilitate, support and/or execute verification of device components and delivery systems
Conduct and/or assist investigations of parenteral packaging and related delivery device failures to determine root causes and work with teams to implement appropriate corrective and preventative actions.
Drive testing activities, protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products.
Author and support regulatory submission content and respond to packaging-related regulatory inquiries.
Collaborate & Influence
Partner closely with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions to ensure alignment and proactive issue resolution.
Lead cross-functional initiatives to harmonize laboratory and business processes across teams and sites.
Support the transfer of new drug products to commercial manufacturing and post-launch support teams.
Innovate & Improve
Contribute to continuous improvement initiatives to enhance efficiency, quality, and scalability of lab and design control processes.
Identify and implement best practices, tools, and strategies that strengthen DPDD capabilities and future readiness.
Who You Are
A confident technical SME with deep expertise in parenteral packaging and medical device/combination product development.
Comfortable working independently while influencing across complex, global, matrixed organizations.
Known for attention to detail, strong judgment, and ability to balance multiple priorities.
A collaborative communicator who can translate complex technical concepts into clear, actionable guidance.
Why Join Us
Perform work that directly supports the development of life-changing medicines
Influence strategy and operations at a global scale
Grow your career in an environment that values innovation, collaboration, and continuous improvement
Be part of a culture that invests in people and rewards leadership
Qualifications
Must Have
BA/BS with 9 to 11 years of experience or MBA/MS with 7 to 8 years of experience
PhD with 0 to 3 years of experience
Strong technical skills in formulation development and process optimization
Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, MIMAS, Computrac, plunger movement chambers)
Proficiency in using analytical instruments and techniques
Experience in cGMP manufacturing and clinical trials supply chain management
Ability to work independently and proactively within a team
Excellent organizational and time management skills
Strong communication and critical thinking abilities
Nice to Have
Proficiency with analytical instruments such as HPLC/UPLC, SEC, LC-MS, BiaCORE, DSC, and GC
Experience with methods to determine formulation content, including drug, polymer, lipid, and in vitro release
Experience in authoring and reviewing technical documentation
Strong data management skills, including data processing and report writing
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Technical Expertise
Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, MIMAS, Computrac, plunger movement chambers)
Experience in GMP and/or ISO 13485 environments
In-depth understanding of global regulatory and quality standards (FDA, ICH, ISO 13485, 11040, 10993, USP/EP/JP compendia, combination product regulations)
Ability to interface with regulatory agencies and provide sound technical justifications
Work Environment & Travel
Combination of laboratory and office-based work
Occasional travel (approximately 5-10%) to other sites, vendors, and conferences
Other Job details
Relocation support available
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to makewww.pfizer.com/careersaccessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please emaildisabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Our Health and Science System Specialists Team provides leadership across patient care settings in the complex Hospital, Health System, and Key Medical Group environment to bring value to our customers and patients in this dynamic ecosystem.
Pharmaceutical and medicine manufacturing
10,000+ Employees
New York, NY, US
1849
