Sr. Packaging Engineer
Pfizer
3 months ago
On-site
Andover, MA
$93,600 - $156,000 USD yearly
Operations
Responsibilities:
- Evaluate, develop, qualify, and implement new components and container closure systems for early/late-stage projects.
- Support formulation and process development teams (Andover and St. Louis) to meet regulatory requirements/guidance for packaging components.
- Author and/or review engineering/development documentation (drawings/specifications, assembly drawings, tolerance stack analyses, risk analyses).
- Participate in design control teams to author/review design verification documentation, specifications, component/device requirements, functionality assessments, and risk assessments.
- Facilitate/support/execute verification of device components and delivery systems.
- Investigate parenteral packaging and delivery device failures to determine root cause; implement corrective and preventative actions.
- Drive testing activities and documentation (protocols, work instructions, lab notebooks, technical reports).
- Author regulatory submission content and respond to packaging-related regulatory inquiries.
Qualifications:
Must Have:
- BA/BS with 9–11 years (or MBA/MS with 7–8 years) or PhD with 0–3 years.
- Strong formulation development and process optimization skills.
- Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, MIMAS, Computrac, plunger movement chambers).
- Proficiency with analytical instruments/techniques.
- Experience with cGMP manufacturing and clinical trials supply chain management.
- Independent, proactive teamwork; strong organization/time management; strong communication and critical thinking.
Nice to Have:
- HPLC/UPLC, SEC, LC-MS, BiaCORE, DSC, GC; formulation content methods (drug/polymer/lipid/in vitro release); technical documentation/data reporting; AI tools (e.g., ChatGPT/Copilot) and responsible AI awareness.
Benefits (explicitly stated):
- Base salary: $93,600–$156,000; bonus target 12.5% and eligible long-term incentive.
- 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision.
Application instructions: Not provided.
- Evaluate, develop, qualify, and implement new components and container closure systems for early/late-stage projects.
- Support formulation and process development teams (Andover and St. Louis) to meet regulatory requirements/guidance for packaging components.
- Author and/or review engineering/development documentation (drawings/specifications, assembly drawings, tolerance stack analyses, risk analyses).
- Participate in design control teams to author/review design verification documentation, specifications, component/device requirements, functionality assessments, and risk assessments.
- Facilitate/support/execute verification of device components and delivery systems.
- Investigate parenteral packaging and delivery device failures to determine root cause; implement corrective and preventative actions.
- Drive testing activities and documentation (protocols, work instructions, lab notebooks, technical reports).
- Author regulatory submission content and respond to packaging-related regulatory inquiries.
Qualifications:
Must Have:
- BA/BS with 9–11 years (or MBA/MS with 7–8 years) or PhD with 0–3 years.
- Strong formulation development and process optimization skills.
- Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, MIMAS, Computrac, plunger movement chambers).
- Proficiency with analytical instruments/techniques.
- Experience with cGMP manufacturing and clinical trials supply chain management.
- Independent, proactive teamwork; strong organization/time management; strong communication and critical thinking.
Nice to Have:
- HPLC/UPLC, SEC, LC-MS, BiaCORE, DSC, GC; formulation content methods (drug/polymer/lipid/in vitro release); technical documentation/data reporting; AI tools (e.g., ChatGPT/Copilot) and responsible AI awareness.
Benefits (explicitly stated):
- Base salary: $93,600–$156,000; bonus target 12.5% and eligible long-term incentive.
- 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision.
Application instructions: Not provided.