Principal Packaging Engineer- Drug Product Design & Development

Pfizer Pfizer · Pharma · MO

This role is for a Principal Packaging Engineer in Biotherapeutics Pharmaceutical Research & Development at Pfizer. The individual will lead a team, provide strategic direction for laboratory operations supporting drug product and combination product development, and champion quality and compliance. Responsibilities include overseeing testing activities, component and container closure system selection, and authoring regulatory submission content. The role requires strong expertise in parenteral packaging, medical device/combination product development, and experience in GMP/ISO 13485 environments.

What you'd actually do

  1. Provide strategic direction and day-to-day leadership for laboratory operations supporting drug product and combination product development.
  2. Mentor, develop, and empower a high-performing team, fostering technical excellence, accountability, and professional growth.
  3. Act as the subject matter expert for laboratory operations, ensuring compliance with ISO 13485, GMP, and internal quality systems.
  4. Oversee and review testing activities, protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products.
  5. Lead component and container closure system selection, qualification, and development activities.

Skills

Required

  • 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
  • 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)
  • Demonstrated success leading teams and cross-functional initiatives
  • Excellent written, verbal, and presentation skills

Nice to have

  • Ability to interface with regulatory agencies and provide sound technical justifications
  • Strong project management and stakeholder engagement capabilities

What the JD emphasized

  • ISO 13485
  • GMP