Sr. Packaging Engineer

Biotherapeutics Pharmaceutical Research & Development Drug Product Design & Development Engineer

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 commercializationultimately 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 510%) to other sites, vendors, and conferences

Other Job Details

• Relocation support available
• Work Location Assignment: On Premise