BSA Lead Production Technician
Sanofi
June 24, 2026
On-site
Swiftwater, PA
$27.08 - $36.11 USD yearly
Operations
Main Responsibilities:
- Perform BSA production in accordance with business needs and effective procedures.
- Ensure required materials are available prior to need.
- Complete sampling and corresponding documentation.
- Complete move tickets and picklists accurately and timely to ensure inventory accuracy.
- Use systems: SAP, Trackwise, Labware; and building/process systems (SFD, PI, Metasys, Labwatch).
- Resolve production issues; understand next steps and guide others through the process.
- Ensure facility areas are adequately covered; plan and work ahead.
- Complete cGMP-required tasks and documentation; complete at least one developmental class annually (and at least one outside core competencies).
- Become trained in all assigned training modules.
- Serve as Training Coordinator/Trainer: train personnel on work procedures, equipment use, cGMP, safe work techniques, and SAP signoffs.
- Maintain qualified trainer status; follow safety procedures; participate in monthly safety meetings and safety walkthroughs; report safety issues/incidents/near misses; lead safety team efforts and safety initiatives; ensure safety training completion.
- Ensure safe, efficacious product; apply knowledge of cGMP; identify deficiencies/deviations; support investigations and root cause analysis.
- Complete and review quality documentation (deviation investigations, BPRs, logbooks); release commodities as required; support deviation/change/CAPA timelines.
- Lead/participate in team and cross-functional meetings; communicate improvements and issues; mentor team members.
- Lead Operator/Room Lead/SME for BSA areas; may lead across processing areas; schedule staff, address issues, reduce operator errors.
- Inform managers of production problems and recommend solutions.
- Ensure timely/accurate documentation; understand entire BSA process and related department interfaces.
- Break down problems using proven approaches; write/review/revise BPRs, SOPs, and SWIs as needed.
- Continually monitor production with emphasis on safety, quality, efficiency, and cost.
- Coordinate equipment repair, PMs, and calibration. Other duties as assigned.
Requirements / Qualifications:
- Experience in a cGMP area; prior/related experience recommended.
- Knowledge and access to SAP (including key user access).
- Knowledge/access to applicable building/process systems (SFD, PI); qualified to complete BPR section reviews.
- Good mechanical skills and computer skills; detail oriented; basic mechanical aptitude; strong comprehension, retention, troubleshooting, and manual dexterity.
- HS equivalent with 5+ years in cGMP/pharmaceutical experience OR Associate degree with 3+ years OR Bachelor’s with 2+ years.
Preferred Qualifications:
- Meet all Sr. Production Technician requirements.
- 1+ year leading teams in a production environment and 1+ years training others in cGMP tasks.
- Perform BSA production in accordance with business needs and effective procedures.
- Ensure required materials are available prior to need.
- Complete sampling and corresponding documentation.
- Complete move tickets and picklists accurately and timely to ensure inventory accuracy.
- Use systems: SAP, Trackwise, Labware; and building/process systems (SFD, PI, Metasys, Labwatch).
- Resolve production issues; understand next steps and guide others through the process.
- Ensure facility areas are adequately covered; plan and work ahead.
- Complete cGMP-required tasks and documentation; complete at least one developmental class annually (and at least one outside core competencies).
- Become trained in all assigned training modules.
- Serve as Training Coordinator/Trainer: train personnel on work procedures, equipment use, cGMP, safe work techniques, and SAP signoffs.
- Maintain qualified trainer status; follow safety procedures; participate in monthly safety meetings and safety walkthroughs; report safety issues/incidents/near misses; lead safety team efforts and safety initiatives; ensure safety training completion.
- Ensure safe, efficacious product; apply knowledge of cGMP; identify deficiencies/deviations; support investigations and root cause analysis.
- Complete and review quality documentation (deviation investigations, BPRs, logbooks); release commodities as required; support deviation/change/CAPA timelines.
- Lead/participate in team and cross-functional meetings; communicate improvements and issues; mentor team members.
- Lead Operator/Room Lead/SME for BSA areas; may lead across processing areas; schedule staff, address issues, reduce operator errors.
- Inform managers of production problems and recommend solutions.
- Ensure timely/accurate documentation; understand entire BSA process and related department interfaces.
- Break down problems using proven approaches; write/review/revise BPRs, SOPs, and SWIs as needed.
- Continually monitor production with emphasis on safety, quality, efficiency, and cost.
- Coordinate equipment repair, PMs, and calibration. Other duties as assigned.
Requirements / Qualifications:
- Experience in a cGMP area; prior/related experience recommended.
- Knowledge and access to SAP (including key user access).
- Knowledge/access to applicable building/process systems (SFD, PI); qualified to complete BPR section reviews.
- Good mechanical skills and computer skills; detail oriented; basic mechanical aptitude; strong comprehension, retention, troubleshooting, and manual dexterity.
- HS equivalent with 5+ years in cGMP/pharmaceutical experience OR Associate degree with 3+ years OR Bachelor’s with 2+ years.
Preferred Qualifications:
- Meet all Sr. Production Technician requirements.
- 1+ year leading teams in a production environment and 1+ years training others in cGMP tasks.