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Sanofi Group Lead Production Technician - Vaccines in Swiftwater, Pennsylvania

This is a 2nd shift position.

Performs production in accordance with volume fluctuation, business need, and effective procedures in BSA, Polysaccharide & Conjugation Operations at Building 56. This position is responsible for manufacturing activities and leading a team in the assigned area. Like all production positions at the Company, this position may be required to be moved or temporarily flexed to another department or location within the Biologics platform due to business needs. We will attempt to provide as much advance notice as possible if any such change is needed.

  • Is a trained designee to supervise shop floor activities included but not limited to Upstream, Downstream, and BSA responsibilities.

  • Ensure operational areas are running as intended to meet all operational goals.

  • Is accountable for the completion of Flu operations including Metasys and Labwatch, corresponding documentation, data entry, etc.

  • Real time review of process documentation.

  • Must be able to maintain qualification of area specific training.

  • Participates or leads in all aspects of production process (SAP, Labware if required, Trackwise, eDoc, HMI, etc.).

  • Works to resolve all production issues. Understands next steps and works to guide others through the process to complete them.

  • Ensures operational areas are staffed adequately staffed at all times and manages breaks.

  • Acts as a liaison for Production and Senior Techs to dictate support.

  • Ensure preparedness for oncoming shifts.

  • Assists in completion of required BPR updates.

  • Works with senior technicians and managers to ensure continuous operation.

  • Maintains aseptic work environment.

This role is for a nonexempt employee working in the FLU Department. Their Bi-weekly pay is based on previous experience and education time.

Their responsibilities are, but are not limited to:

Safety:

  • Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings.

  • Reports all safety issues, concerns, incidents and near misses to the team leadership.

  • Actively participates in safety walkthroughs coordinated by the department’s safety team.

  • Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

  • Ensures proper training and safety practices are followed in the areas.

  • Follows effective procedures to ensure the production of a safe and efficacious product.

  • Utilizes +QDCI boards for Safety issues.

  • Uses HSE Trackwise as needed.

Quality:

  • FDA audit understanding and awareness. Ensures process in areas is following proper procedures at all times

  • Identifies possible deviation occurrences and prevents or aids in investigations and root cause analysis.

  • Participate in completing at least one incident investigations, one CAPA action item, or one change control action item, along with projects.

  • Ensures completion and review of quality documentation (BPR’s, logbooks, etc.) accurately in a timely manner for process area assigned.

  • Understands the function of the quality group and works with them to maintain a positive rapport.

  • Writes edits and reviews process documentation for completeness.

  • Identifies areas of deficiency and offers suggestions for improvements.

  • Maintains acceptable execution with no emerging negative trends in procedural deviations.

  • Uses Trackwise to imitate and write deviations and CAPAs as needed.

Delivery:

  • Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.

  • Completes tasks and corresponding documentation as required by cGMP to ensure document completion and real time review.

  • Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing.

  • All other duties as assigned. Adheres to all other company time keeping and attendance policies.

  • Accountable for the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.

  • Post completion, reviewed BPR prior to BPR review delivery to ensure no documentation errors remain.

Cost:

  • Executes procedure as documented to avoid deviations.

  • Responsibly uses material in an efficient manner to reduce waste.

  • Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.

  • Works to resolve all production issues related to area of work.

Involvement:

  • Works to become trained in all assigned training modules.

  • Trains and orients new team members (at any level) as assigned. Mentors Associate and Production techs.

  • Participates and leads team meetings. Understands respect, professionalism and confidentiality.

  • Ensures all materials required for production are available prior to need.

  • Follows proper documentation as required by cGMP.

  • Has a thorough working knowledge of cGMP’s and works to help others understand.

  • Ensures all areas within the department are adequately covered at all time for current shift and upcoming shifts.

  • In on time and attends and participates in Shift Change.

  • Involved in at least one cross functional teams where necessary to complete projects in an effective and timely manner.

  • Trainer –Train and guide Personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

All other duties as assigned.

EDUCATION/EXPERIENCE:

  • High School or equivalent diploma with 5 years’ experience in cGMP or Pharmaceutical industry.

  • Associates with 3 years’ experience in cGMP or Pharmaceutical industry.

  • Bachelor’s Degree with 2 years’ experience in cGMP or Pharmaceutical industry.

  • Must meet all Sr. Production Technician requirements.

  • Additionally must have 1 + year leading teams in a Production environment.

  • Must maintain training on all area designee modules.

  • Must be considered an SME in at least one processing area.

  • Must be qualified to complete BPR final reviews.

Thorough knowledge of cGMPs and regulatory requirements are required. Must have knowledge and access to systems (SAP, Trackwise, Master Labware, HSE Trackwise, key user access to SAP). Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI, BAS)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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