Principal Packaging Engineer- Drug Product Design & Development

Pfizer Pfizer · Pharma · MO

Principal Packaging Engineer role at Pfizer focused on leading packaging and laboratory operations for drug-device combination products. Requires expertise in GMP, ISO 13485, and global regulatory standards, with a focus on quality, compliance, and continuous improvement. The role involves team leadership, technical guidance, and collaboration with cross-functional teams to advance products from development to commercialization.

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. Drive continuous improvement initiatives to enhance efficiency, quality, and scalability of lab and design control processes.

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
  • Strong project management and stakeholder engagement capabilities

Nice to have

  • Ability to interface with regulatory agencies and provide sound technical justifications

What the JD emphasized

  • ISO 13485
  • GMP