Sr. Packaging Engineer
Pfizer
3 months ago
On-site
Chesterfield, MO
Operations
Responsibilities:
- Evaluate, develop, qualify, and implement new components and container closure systems for early and late-stage projects.
- Work with vendors, R&D SMEs, and commercial site SMEs on parenteral packaging/medical device development activities.
- Support formulation and process development teams (Andover and St. Louis) to comply with regulatory requirements and guidance related to components and container closure systems.
- Author and/or review engineering and development documentation (component drawings/specifications, assembly drawings, tolerance stack analyses, risk analyses).
- Participate on design control teams; author/review design verification supporting documentation, specifications, component/device requirements, functionality assessments, and risk assessments.
- Facilitate, support, and/or execute verification of device components and delivery systems.
- Investigate parenteral packaging and delivery device failures to determine root causes and drive corrective and preventative actions.
- Drive testing activities and produce protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products.
- Author/support regulatory submission content and respond to packaging-related regulatory inquiries.
- Partner cross-functionally with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions; lead initiatives to harmonize processes; support transfers to commercial manufacturing and post-launch teams.
- Contribute to continuous improvement and identify best practices/tools/strategies to strengthen DPDD capabilities.
Qualifications:
- BA/BS with 9–11 years of experience, or MBA/MS with 7–8 years of experience; or PhD with 0–3 years of experience.
- Strong technical skills in formulation development and process optimization.
- Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, MIMAS, Computrac, plunger movement chambers).
- Proficiency with analytical instruments and techniques.
- Experience with cGMP manufacturing and clinical trials supply chain management.
- Ability to work independently and proactively; excellent organizational/time management skills.
- Strong communication and critical thinking.
Preferred/Nice to Have:
- Proficiency with analytical instruments (HPLC/UPLC, SEC, LC-MS, BiaCORE, DSC, GC).
- Experience determining formulation content (drug, polymer, lipid, in vitro release).
- Experience authoring/reviewing technical documentation; strong data management/report writing.
- Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) for problem solving and productivity; understanding of responsible AI practices.
Technical Expertise:
- Experience in GMP and/or ISO 13485 environments.
- Knowledge of global regulatory/quality standards (FDA, ICH, ISO 13485, 11040, 10993, USP/EP/JP compendia, combination product regulations).
- Ability to interface with regulatory agencies and provide technical justifications.
Benefits (if part of job description):
- Eligible for participation in Global Performance Plan (bonus target 12.5% of base salary) and share-based long-term incentive program; comprehensive benefits including 401(k) with matching, paid time off, caregiver/parental and medical leave, and medical/prescription/dental/vision.
Other job details (included where explicitly stated):
- Relocation support available; Work Location Assignment: On Premise; occasional travel ~5–10%.
- Annual base salary range: $93,600–$156,000.
- Evaluate, develop, qualify, and implement new components and container closure systems for early and late-stage projects.
- Work with vendors, R&D SMEs, and commercial site SMEs on parenteral packaging/medical device development activities.
- Support formulation and process development teams (Andover and St. Louis) to comply with regulatory requirements and guidance related to components and container closure systems.
- Author and/or review engineering and development documentation (component drawings/specifications, assembly drawings, tolerance stack analyses, risk analyses).
- Participate on design control teams; author/review design verification supporting documentation, specifications, component/device requirements, functionality assessments, and risk assessments.
- Facilitate, support, and/or execute verification of device components and delivery systems.
- Investigate parenteral packaging and delivery device failures to determine root causes and drive corrective and preventative actions.
- Drive testing activities and produce protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products.
- Author/support regulatory submission content and respond to packaging-related regulatory inquiries.
- Partner cross-functionally with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions; lead initiatives to harmonize processes; support transfers to commercial manufacturing and post-launch teams.
- Contribute to continuous improvement and identify best practices/tools/strategies to strengthen DPDD capabilities.
Qualifications:
- BA/BS with 9–11 years of experience, or MBA/MS with 7–8 years of experience; or PhD with 0–3 years of experience.
- Strong technical skills in formulation development and process optimization.
- Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, MIMAS, Computrac, plunger movement chambers).
- Proficiency with analytical instruments and techniques.
- Experience with cGMP manufacturing and clinical trials supply chain management.
- Ability to work independently and proactively; excellent organizational/time management skills.
- Strong communication and critical thinking.
Preferred/Nice to Have:
- Proficiency with analytical instruments (HPLC/UPLC, SEC, LC-MS, BiaCORE, DSC, GC).
- Experience determining formulation content (drug, polymer, lipid, in vitro release).
- Experience authoring/reviewing technical documentation; strong data management/report writing.
- Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) for problem solving and productivity; understanding of responsible AI practices.
Technical Expertise:
- Experience in GMP and/or ISO 13485 environments.
- Knowledge of global regulatory/quality standards (FDA, ICH, ISO 13485, 11040, 10993, USP/EP/JP compendia, combination product regulations).
- Ability to interface with regulatory agencies and provide technical justifications.
Benefits (if part of job description):
- Eligible for participation in Global Performance Plan (bonus target 12.5% of base salary) and share-based long-term incentive program; comprehensive benefits including 401(k) with matching, paid time off, caregiver/parental and medical leave, and medical/prescription/dental/vision.
Other job details (included where explicitly stated):
- Relocation support available; Work Location Assignment: On Premise; occasional travel ~5–10%.
- Annual base salary range: $93,600–$156,000.