Senior Production Technician
Sanofi
4 months ago
On-site
Swiftwater, PA
Operations
First shift position in SEED (some off-shift work may be required based on project phase or business need).
Responsibilities:
- Perform production per volume fluctuation, business need, and effective procedures.
- Ensure required materials are available prior to production.
- Complete sampling and corresponding documentation.
- Complete move tickets and picklists accurately and on time to maintain inventory.
- Participate in or lead production process activities (iSHIFT, cycle counting, ONELims, Qualipso, ordering, Labwatch, Metasys, etc.).
- Resolve production issues; understand next steps and guide others through completion.
- Understand science behind process steps/technology.
- Ensure facility areas are adequately covered at all times; may serve as processing room lead.
- Complete cGMP-required tasks and documentation.
- Maintain training: complete developmental classes (at least one annually in addition to at least one outside core competencies) and become trained in assigned training modules.
- Training Coordinator/Trainer: train/guide personnel on work procedures, equipment use, cGMPs, safe work techniques, and SAP.
- Maintain qualified trainer status.
- Follow safety procedures; participate in monthly safety meetings and safety walkthroughs; report safety issues/incidents/near misses; support corrective/preventive actions and safety initiatives; ensure safety training completion.
- Follow procedures to produce a safe and efficacious product; use thorough cGMP knowledge.
- Identify deficiencies and suggest improvements; identify deviations and support investigations/root cause analysis.
- Complete and review quality documentation (eBRs, elogbooks, etc.) for accuracy and completeness.
- Work with quality group and participate in cross-functional teams; perform all other duties as assigned.
Basic Qualifications:
- HS diploma or equivalent + 3+ years in cGMP or Pharmaceutical experience.
- Associate: 2+ years in cGMP or Pharmaceutical experience.
- Bachelor’s: 0–1+ years in cGMP or Pharmaceutical experience.
Preferred Qualifications / Skills:
- Prior/related cGMP or Pharmaceutical experience.
- Proficiency in at least two areas of operations or product line.
- Qualified trainer in one or more areas.
- Proficiency in at least one: BPR review, Environmental monitoring, Documentation Coordinator, logbook review, technical writing (SWI revisions).
- Knowledge/access to systems: iShift, Qualipso, OneLIMS, Labware; and applicable systems in relevant buildings/processes (e.g., SFD, PI).
Benefits:
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.
- At least 14 weeks’ gender-neutral parental leave.
Responsibilities:
- Perform production per volume fluctuation, business need, and effective procedures.
- Ensure required materials are available prior to production.
- Complete sampling and corresponding documentation.
- Complete move tickets and picklists accurately and on time to maintain inventory.
- Participate in or lead production process activities (iSHIFT, cycle counting, ONELims, Qualipso, ordering, Labwatch, Metasys, etc.).
- Resolve production issues; understand next steps and guide others through completion.
- Understand science behind process steps/technology.
- Ensure facility areas are adequately covered at all times; may serve as processing room lead.
- Complete cGMP-required tasks and documentation.
- Maintain training: complete developmental classes (at least one annually in addition to at least one outside core competencies) and become trained in assigned training modules.
- Training Coordinator/Trainer: train/guide personnel on work procedures, equipment use, cGMPs, safe work techniques, and SAP.
- Maintain qualified trainer status.
- Follow safety procedures; participate in monthly safety meetings and safety walkthroughs; report safety issues/incidents/near misses; support corrective/preventive actions and safety initiatives; ensure safety training completion.
- Follow procedures to produce a safe and efficacious product; use thorough cGMP knowledge.
- Identify deficiencies and suggest improvements; identify deviations and support investigations/root cause analysis.
- Complete and review quality documentation (eBRs, elogbooks, etc.) for accuracy and completeness.
- Work with quality group and participate in cross-functional teams; perform all other duties as assigned.
Basic Qualifications:
- HS diploma or equivalent + 3+ years in cGMP or Pharmaceutical experience.
- Associate: 2+ years in cGMP or Pharmaceutical experience.
- Bachelor’s: 0–1+ years in cGMP or Pharmaceutical experience.
Preferred Qualifications / Skills:
- Prior/related cGMP or Pharmaceutical experience.
- Proficiency in at least two areas of operations or product line.
- Qualified trainer in one or more areas.
- Proficiency in at least one: BPR review, Environmental monitoring, Documentation Coordinator, logbook review, technical writing (SWI revisions).
- Knowledge/access to systems: iShift, Qualipso, OneLIMS, Labware; and applicable systems in relevant buildings/processes (e.g., SFD, PI).
Benefits:
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.
- At least 14 weeks’ gender-neutral parental leave.