Job Title: Senior Production Technician Vaccines

Location: Swiftwater, PA

Shift: 1st shift

About the job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

The Senior Production Technician will ensure the operational area is running as intended to meet all operational goals. Ensure the completion of Environmental Monitoring sampling and corresponding documentation, data entry, and delivery as required during all aseptic processing. Real-time review of this documentation.

About Sanofi

Werean R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities:

• 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 departments safety team.

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

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

• Utilizes +QDCI boards for Safety issues

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 (BFRs, 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

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.

• Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.

• Ensure proper septic set up and installation of aseptic fill parts and Filler set up. This is done in a Grade A environment. Must ensure maintenance of gowning and Physical dexterity to complete proper set up of machines so not to impact the safety, quality, and integrity of the product.

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

• Ensures all Final Container materials required for production are available prior to need. These materials must be ready for aseptic filling operations to ensure the safety, quality, purity, and integrity of the product is maintained.

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

Cost:

• Executes procedure as documented to avoid deviations.

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

• Utilized Filling Standards to capture and Record HRxHR and Change Over Activities.

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

• Works to resolve common 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 cGMPs 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.

• Training coordinator / Trainer Train and guide Personnel in proper work procedures, use of equipment, cGMPs, safe work techniques and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

All other duties as assigned.

• Must be able to completed and maintain qualification of utility sampling of WFI, Clean Steam, and DI as required to keep building GMP.

• Participates or leads in all aspects of production process (SAP, Labware if required, Trackwise, RT Reports , eDoc, HMI, SCADA access, Virtual Standards, etc.).

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

• Understands science behind process steps and technology including aseptic processing. This including working knowledge of complex automation system used in Filling as well as Operator access to these systems ( SCADA, INOVA FILLER, Depy Tunnel, EMS, PMS, etc).

• Ensures operational area is adequately staffed at all times.

• May serve as Preparation or Aseptic room leads and strive to become experts in their assigned areas

• Assists in completion of required BFR updates.

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

• Maintains aseptic work environment.

About you

Basic Qualifications:

• Requires good mechanical skills, computer skills, and is detail-oriented.

• Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting, and manual dexterity.

• Prior or related cGMP or Pharmaceutical experience recommended

• HS diploma or equivalent and 3+ years in cGMP or Pharmaceutical experience

• Associate's with 2+ years in cGMP or Pharmaceutical experience

• Bachelor's with 1+ years in cGMP or Pharmaceutical experience

• Proficiency in at least, but not limited to, three areas of operations or product line.

• Must be a qualified trainer in one or more areas. Must be proficient in at least one of the following areas: BFR review, Environmental monitoring, Utility Sampling, Documentation Coordinator, logbook review, technical writing (SWI revisions).

• Must have knowledge and access to systems (SAP, Trackwise, Master, EMS, PMS, SCADA, RT Reports, Labware).

• Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI)

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.