Principal Packaging Engineer- Drug Product Design & Development

Role Summary

This role is in the Biotherapeutics Pharmaceutical Research and Development Drug Product Design & Development group located in Chesterfield, MO and Andover, MA. The position requires collaborating with the Quality & Compliance organization to champion quality in lab operations to ensure compliance with standards and supports manager forums and new hire onboarding activities. Responsibilities include supplying packaging deliverables and support required for new drug product development, authoring required regulatory submission sections, addressing packaging/component related queries and contributing to the transfer of new drug products to commercial manufacturing sites. In addition to these responsibilities, this role includes providing strategic direction for project teams, nurturing professional growth for team members, and ensuring accountability to drive successful execution across initiatives. This leader will foster a culture of continuous improvement and drive initiatives to enhance operational efficiency.

Responsibilities

• Deliver activities associated with component and container closure system selection, qualification, development, and design control packaging engineer deliverables for medical devices and combination products (MDCP).
• Work on and supervise lab activities related to testing and investigation of MDCPs.
• Act as a subject matter expert for laboratory operations to effectively manage the labs and maintain compliance to ISO 13485.
• Accountable for equipment calibration/qualification in accordance with Pfizer’s Quality Management System.
• Support electronic lab notebook super user and ensure compliance of lab notebooks with department procedures and best practices.
• Develop and manage technical development needs of junior staff as appropriate.
• Assist project and group leads in developing goals and contribute to reviews for other packaging engineers.
• Oversee day-to-day running of laboratories and supervise laboratory resources to meet DPDD objectives.
• Review testing work instructions, test protocols, lab notebooks and reports.
• Develop and expand technical expertise and skills of the team to meet DPDD requirements and direction.
• Act as SME for laboratory operations to ensure compliance with ISO 13485 and effective management within labs.
• Optimize processes and implement initiatives to improve quality and efficiency in support of Design Control projects.
• Foster collaboration across DPDD functions to provide packaging knowledge for project needs.
• Engage with multiple business functions (MT, EHS, Facilities, Quality, GWS) to align, identify trends, and resolve issues.
• Lead and manage cross-functional project teams to harmonize lab and business processes; oversee direct reports for consistent execution and accountability.
• Work with local/global EHS teams to maintain safety process compliance.
• Support lab notebook governance and drive continuous improvement of systems/processes with eLN superuser.
• Develop goals and contribute to reviews for supervised packaging engineers.

Qualifications

• Bachelor’s Degree in a relevant Science & Engineering discipline (e.g., Packaging, Mechanical, Materials, Biomedical, Chemical), Chemistry, Biochemistry; or related field with a minimum of 12 years OR 10+ years with MBA/MS in Pharmaceutical Parenteral Packaging Development.
• PhD with 8+ years of experience.
• Knowledge of parenteral packaging, components and testing equipment (e.g., Instron, ZebraSci, Computrac, plunger movement chamber).
• Experience in GMP environment or ISO 13485 framework.
• Knowledge of packaging-related regulatory standards and guidance.
• Ability to work independently with minimal supervision; high attention to technical details and accuracy.
• Ability to prioritize multiple responsibilities and manage multiple tasks simultaneously.
• Demonstrated ability to work collaboratively in cross-functional teams.
• Excellent communication (oral, written, presentation) and interpersonal skills.
• Proficiency in general computer software (word processing, spreadsheets, presentations).

Skills

• Key Technical Skills: Knowledge of current US/global regulations, compendia, ISO standards (ISO 13485, 11040, 10993), quality system regulations for combination products, and FDA/ICH guidance. Ability to interface with regulatory agencies and justify packaging decisions. Understanding of component selection and device design activities. Broad packaging knowledge across Pfizer and related functions. Familiarity with project management methodologies and providing technical leadership for projects.

Education

• Bachelor’s Degree in a relevant science/engineering field (Packaging, Mechanical, Materials, Biomedical, Chemical, Chemistry, Biochemistry) or related field.
• Advanced degree (MBA/MS or PhD) preferred in relevant experience paths for higher-level roles.

Additional Requirements

• Physical/Mental Requirements: Ability to work in a lab and office environment.
• Non-standard Work Schedule, Travel Or Environment: Travel 5 - 10% of the time to other Pfizer sites, vendors, conferences, etc.
• Other Job Details: Relocation support available; On Premise work location.