Sr. Packaging Engineer

Pfizer • St Louis, MO

2d • Onsite

About The Position

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.

Requirements

• 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
• 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
• This position requires permanent work authorization in the United States.

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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.

Benefits

• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level