Principal Packaging Engineer – Drug Product Design, Development

Pfizer

. Provide strategic direction and day-to-day leadership for laboratory operations supporting drug product and combination product development .

Posted 5/7/2026full-timeChesterfield • Massachusetts, Montana • 🇺🇸 United StatesLead💰 $106,000 - $176,600 per yearWebsite

About the role

Key responsibilities & impact

Provide strategic direction and day-to-day leadership for laboratory operations supporting drug product and combination product development
Mentor, develop, and empower a high-performing team, fostering technical excellence, accountability, and professional growth
Contribute to goal setting, performance reviews, and career development for packaging engineers
Act as the subject matter expert for laboratory operations, ensuring compliance with ISO 13485, GMP, and internal quality systems
Own equipment calibration and qualification activities in alignment with the Quality Management System
Ensure laboratory notebooks and electronic lab notebook (eLN) systems meet procedural, regulatory, and best-practice standards
Oversee and review testing activities, protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products
Lead component and container closure system selection, qualification, and development activities
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
Drive 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

Requirements

What you’ll need

Bachelor’s degree in Engineering or Science (Packaging, Mechanical, Materials, Biomedical, Chemical, Chemistry, Biochemistry, or related) with 12+ years of relevant experience OR Master’s/MBA with 10+ years of experience OR PhD with 8+ years of experience in pharmaceutical packaging development
Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, 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
Demonstrated success leading teams and cross-functional initiatives
Excellent written, verbal, and presentation skills
Strong project management and stakeholder engagement capabilities

Benefits

Comp & perks

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental and vision coverage

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

packaging developmentequipment calibrationqualification activitiesregulatory submission contenttesting protocolstechnical reportscontinuous improvementproject managementstakeholder engagementcompliance standards

Soft Skills

leadershipmentoringteam developmentaccountabilityprofessional growthcommunicationcollaborationproblem-solvingstrategic directioncross-functional leadership

Certifications

Bachelor’s degree in Engineering or ScienceMaster’s degreeMBAPhDISO 13485GMP