Principal Packaging Engineer- Drug Product Design & Development

Role Summary

Principal Packaging Engineer- Drug Product Design & Development in the Biotherapeutics Pharmaceutical Research and Development DPDD group located in Chesterfield, MO and Andover, MA. Partners with Quality & Compliance to champion quality in lab operations and supports manager forums and new hire onboarding. Responsible for supplying packaging deliverables, supporting new drug product development, authoring regulatory submission sections, addressing packaging/component queries, and contributing to transfer of new drug products to commercial manufacturing sites.

Responsibilities

• 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 in 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.

Qualifications

• Bachelor's Degree in appropriate Science & Engineering disciplines (e.g., Engineering—Packaging, Mechanical, Materials, Biomedical, Chemical; Chemistry, Biochemistry) with a minimum of 12 years OR 10+ years with an MBA/MS degree with relevant experience in Pharmaceutical Parenteral Packaging Development.
• PhD Degree with 8+ years of experience.
• Knowledge in parenteral packaging, component, and component testing equipment (e.g., Instron, ZebraSci, Computrac, plunger movement chamber).
• Experience in GMP environment or equivalent (e.g., ISO 13485).
• 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 tasks.
• 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

• Knowledge of current US and global Regulations, US/EU/JP Compendia, ISO standards (ISO 13485, 11040, 10993), quality system regulations (Part 4) for combination products, Container Closure Systems for Packaging Human Drugs and Biologics FDA guidance and other FDA/ICH guidance.
• Ability to interface with regulatory agencies to provide packaging rationale and justifications as needed.
• Understanding of component selection and device design activities.
• Breadth of packaging understanding within and outside Pfizer.
• Understanding of project management methodologies and ability to provide technical leadership for projects; collaborate across partner lines and share knowledge to define packaging strategy.

Education

• Bachelor's Degree in Science & Engineering disciplines (Packaging, Mechanical, Materials, Biomedical, Chemical, Chemistry, Biochemistry) or related field; advanced degrees or MBA/MS preferred.

Additional Requirements

• Travel: 5 - 10% of the time (other Pfizer sites, vendors, conferences, etc.).
• Physical/Mental Requirements: Ability to work in a lab and office environment.