The Principal Packaging Engineer will oversee lab operations manage packaging development projects ensure compliance with standards and provide strategic direction to teams.

About the Role
We are seeking an accomplished and forward-thinking leader to join our Biotherapeutics Pharmaceutical Research & Development - Drug Product Design & Development (DPDD) organization. In this highly visible role you will shape the future of packaging and laboratory operations for innovative drug-device combination products while championing quality compliance and continuous improvement.
You will lead and inspire a team of packaging engineers and laboratory professionals serving as both a technical authority and people leader. 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.
What You'll Do

• Lead & Inspire
• 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.

Champion Quality & Compliance
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.
Drive Technical Excellence
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.
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
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.
Who You Are

• A confident technical leader 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
Education & Experience

• 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

Technical Expertise

• 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

Leadership & Communication

• Demonstrated success leading teams and cross-functional initiatives
• Excellent written verbal and presentation skills
• Strong project management and stakeholder engagement capabilities

Work Environment & Travel

• Combination of laboratory and office-based work
• Occasional travel (approximately 5-10%) to other sites vendors and conferences

Why Join Us

• Lead 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

The annual base salary for this position ranges from $106000.00 to $176600.00. In addition this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Research and Development