Sr. Packaging Engineer

Role Summary

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. Location: Andover, MA and St. Louis, MO. Work Location: On Premise.

Responsibilities

• Work closely with vendors, research and development SMEs and commercial Site SMEs 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.

Skills

• 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.

Qualifications

• Must Have: Strong technical skills in formulation development and process optimization
• Must Have: Proficiency in using analytical instruments and techniques
• Must Have: Experience in cGMP manufacturing and clinical trials supply chain management
• Must Have: Ability to work independently and proactively within a team
• Must Have: Excellent organizational and time management skills
• Must Have: Strong communication and critical thinking abilities
• Nice to Have: Proficiency with analytical instruments such as HPLC/UPLC, SEC, LC-MS, BiaCORE, DSC, and GC
• Nice to Have: Experience with methods to determine formulation content, including drug, polymer, lipid, and in vitro release
• Nice to Have: Experience in authoring and reviewing technical documentation
• Nice to Have: Strong data management skills, including data processing and report writing
• Nice to Have: Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity
• Nice to Have: Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Education

• 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

Additional Requirements

• Work Environment: Combination of laboratory and office-based work
• Travel: Occasional travel (approximately 5–10%) to other sites, vendors, and conferences