Principal Packaging Engineer- Drug Product Design & Development
- United States - Missouri - St. Louis - Chesterfield
- United States - Massachusetts - Andover
This position 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. The incumbent will be responsible for delivering the following activities associated with component and container closure system selection, qualification, development, as well as, design control packaging engineer deliverables for medical devices and combination products (MDCP). These activities include:
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 to 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 is accountable for the compliance of the lab notebooks in the department procedures and best practice
Develop and manage technical development needs of junior staff as appropriate
Assists project and group leads in developing goals and contributes to the reviews for other packaging engineers.
Position Responsibilities
Responsible for overseeing the day-to-day running of the laboratories
Provide supervision of the laboratory resources to meet DPDD objectives .
Review testing work instructions, test protocols, lab notebooks and reports
Develop and expand the technical expertise and skills of the team to ensure SMEs have the right skills, knowledge, and tools to keep up with DPDD requirements and direction
Act as subject matter expert for laboratory operations to ensure effective management and control within the labs to maintain compliance to ISO 13485
Accountable for equipment calibrations / qualifications in accordance with Pfizer’s Quality Management System.
Optimize processes, implement initiatives, and strategies to improve processes to maximize the quality and efficiency in support of Design Control projects.
Implement a collaborative relationship between all DPDD business functions to provide effective support and input package engineering technical knowledge for project needs
Interact with and engage with multiple business functions e.g MT, EHS, Facilities, Quality and Global Workplace Solutions (GWS) on a regular basis to ensure alignment, understand trends and resolve issues effectively
Lead and manage cross-functional project teams aimed at harmonizing lab and business processes. Drive process alignment and compliance across functional teams, while overseeing a team of direct reports to ensure consistent execution and accountability.
Work closely with local and global EHS teams to ensure compliance with all safety processes and protocols is maintained
Support lab notebook super user and accountable for the compliance of the lab notebooks in the department; Work with eLN superuser for continuous improvement of system and processes
Developing goals and contributes to the reviews for the supervised packaging engineers
Organizational Relationships:
Combination product development teams – device development leads, human factors SMEs, design engineers and device development scientists
Co-development team – drug product and device SMEs
Quality Assurance
GCMC (Regulatory)
PGS – manufacturing sites and post launch device team
External designers and contract manufacturing organizations
Qualifications
Bachelor's Degree in a appropriate Science & Engineering disciplines, e.g. Engineering (Packaging, Mechanical, Materials, Biomedical, Chemical, etc.), Chemistry, Biochemistry; or other related discipline with a minimum of 12 years OR 10+ years with a MBA/MS degree with relevant experience with 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, etc.
Experience working in a Good Manufacturing Practices (GMP) environment or equivalent, e.g. ISO 13485
Knowledge of packaging related regulatory standards and guidance
Capable of working independently with minimal supervision
High level of attention to technical details and accuracy
Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
Demonstrated ability to work collaboratively in cross functional teams
Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills
Proficiency in general computer software such as word processing, spreadsheets, presentations
Key Technical Skills:
Knowledge of current US and global Regulations, US/EU/JP Compendia, ISO standards (e.g., ISO 13485, 11040, 10993, etc.), quality system regulations (Part 4) for combination products, Container Closure Systems for Packaging Human Drugs and Biologics FDA guidance document, and other applicable FDA and ICH guidance.
Ability to interface with regulatory agencies to provide packaging rationale and justifications as needed
Understand component selection and device design activities
Possess and exercise breadth of packaging understanding within and outside Pfizer
Understand project management methodologies and capable of providing technical leadership for projects. Interact constructively with other partner lines and actively shares knowledge and expertise to define packaging strategy
PHYSICAL/MENTAL REQUIREMENTS
Ability to work in a lab and office environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work-related travel will be 5 - 10% of the time (other Pfizer sites, vendors, conferences, etc.).
Other Job Details
Relocation support available
Work Location Assignment: On Premise
The annual base salary for this position ranges from $102,900.00 to $171,500.00. 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.
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