BSA Lead Production Technician
Sanofi
4 months ago
On-site
Swiftwater, PA
Operations
Main Responsibilities
- Perform production in accordance with business needs and effective procedures.
- Ensure all materials required for production are available prior to need.
- Ensure completion of sampling and corresponding documentation.
- Complete move tickets and picklists accurately and on time to ensure accurate inventory.
- Resolve production issues; understand next steps and guide others through the process.
- Understand the science behind process steps and technology.
- Ensure all facility areas are adequately covered at all times; seek and advise on next steps.
- Ensure team planning and ahead-of-schedule work where possible.
- Complete tasks and documentation as required by cGMP; complete at least one developmental class annually (including at least one outside core competencies).
- Become trained in all assigned training modules.
- Training coordinator/trainer: train and guide personnel on work procedures, equipment use, cGMPs, safe work techniques, and SAP to assure consistent, timely signoffs.
- Maintain qualified trainer status; comply with procedures to ensure safety of self and others.
- Participate in monthly safety meetings; utilize +QDCI boards; report safety issues/concerns/incidents/near misses; participate in safety walkthroughs.
- Provide input for safety improvements and corrective/preventative actions; lead safety team efforts and training on safety initiatives.
- Ensure production of a safe and efficacious product; maintain thorough working knowledge of cGMPs.
- Identify deficiencies and recommend improvements.
- Identify deviations; assist with investigations and root cause analysis.
- Complete quality documentation (deviation investigations, BPRs, logbooks, etc.) accurately and timely; review completeness and release commodities as required.
- Work with quality and technical services on deviations, change controls, documentation, and CAPAs; ensure effective solutions are implemented and trained.
- Participate/lead team and cross-functional meetings; actively communicate improvement ideas, issues, and concerns; mentor team members.
- Lead operator/room lead/SME in BSA areas; ensure “right the first time” quality.
- May provide leadership across processing areas; may schedule assignments and drive continuous incremental improvements to reduce operator errors.
- Inform managers of production problems/concerns and recommend solutions.
- Ensure processes/operations are documented timely and accurately; understand end-to-end BSA process and related business areas.
- Break down problems using proven standard approaches; fully investigate root causes of deviations.
- Write/review/revise BPRs, SOPs, and SWIs as needed.
- Continually monitor production activities with emphasis on safety, quality, efficiency, and cost.
- Ensure site safety and HR policy compliance; coordinate repair, PMs, and calibration of equipment.
- All other duties as assigned.
Requirements / Qualifications
- Experience in a cGMP area; prior/related experience recommended.
- Knowledge and access to systems: SAP (including key user access).
- Knowledge and access to applicable building/process systems (SFD, PI); qualified to complete BPR section reviews.
- Good mechanical and computer skills; detail oriented; mechanical aptitude, comprehension/retention, troubleshooting, and manual dexterity.
Basic Qualifications
- HS equivalent and 5+ years in cGMP or pharmaceutical experience.
- OR Associate’s with 3+ years in cGMP or pharmaceutical experience.
- OR Bachelor’s with 2+ years in cGMP or pharmaceutical experience.
Preferred Qualifications
- Meet all Sr. Production Technician requirements.
- 1+ year leading teams in a production environment.
- 1+ year training others in cGMP tasks.
Benefits (explicitly stated)
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.
- Perform production in accordance with business needs and effective procedures.
- Ensure all materials required for production are available prior to need.
- Ensure completion of sampling and corresponding documentation.
- Complete move tickets and picklists accurately and on time to ensure accurate inventory.
- Resolve production issues; understand next steps and guide others through the process.
- Understand the science behind process steps and technology.
- Ensure all facility areas are adequately covered at all times; seek and advise on next steps.
- Ensure team planning and ahead-of-schedule work where possible.
- Complete tasks and documentation as required by cGMP; complete at least one developmental class annually (including at least one outside core competencies).
- Become trained in all assigned training modules.
- Training coordinator/trainer: train and guide personnel on work procedures, equipment use, cGMPs, safe work techniques, and SAP to assure consistent, timely signoffs.
- Maintain qualified trainer status; comply with procedures to ensure safety of self and others.
- Participate in monthly safety meetings; utilize +QDCI boards; report safety issues/concerns/incidents/near misses; participate in safety walkthroughs.
- Provide input for safety improvements and corrective/preventative actions; lead safety team efforts and training on safety initiatives.
- Ensure production of a safe and efficacious product; maintain thorough working knowledge of cGMPs.
- Identify deficiencies and recommend improvements.
- Identify deviations; assist with investigations and root cause analysis.
- Complete quality documentation (deviation investigations, BPRs, logbooks, etc.) accurately and timely; review completeness and release commodities as required.
- Work with quality and technical services on deviations, change controls, documentation, and CAPAs; ensure effective solutions are implemented and trained.
- Participate/lead team and cross-functional meetings; actively communicate improvement ideas, issues, and concerns; mentor team members.
- Lead operator/room lead/SME in BSA areas; ensure “right the first time” quality.
- May provide leadership across processing areas; may schedule assignments and drive continuous incremental improvements to reduce operator errors.
- Inform managers of production problems/concerns and recommend solutions.
- Ensure processes/operations are documented timely and accurately; understand end-to-end BSA process and related business areas.
- Break down problems using proven standard approaches; fully investigate root causes of deviations.
- Write/review/revise BPRs, SOPs, and SWIs as needed.
- Continually monitor production activities with emphasis on safety, quality, efficiency, and cost.
- Ensure site safety and HR policy compliance; coordinate repair, PMs, and calibration of equipment.
- All other duties as assigned.
Requirements / Qualifications
- Experience in a cGMP area; prior/related experience recommended.
- Knowledge and access to systems: SAP (including key user access).
- Knowledge and access to applicable building/process systems (SFD, PI); qualified to complete BPR section reviews.
- Good mechanical and computer skills; detail oriented; mechanical aptitude, comprehension/retention, troubleshooting, and manual dexterity.
Basic Qualifications
- HS equivalent and 5+ years in cGMP or pharmaceutical experience.
- OR Associate’s with 3+ years in cGMP or pharmaceutical experience.
- OR Bachelor’s with 2+ years in cGMP or pharmaceutical experience.
Preferred Qualifications
- Meet all Sr. Production Technician requirements.
- 1+ year leading teams in a production environment.
- 1+ year training others in cGMP tasks.
Benefits (explicitly stated)
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.