Production Operator- Vaccines

Job Title: Production Operator- Vaccines

Location: Swiftwater, PA

About the Job

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

Performs production in accordance with volume fluctuation, business need, and effective procedures.  Responsible for Manufacturing actives in assigned area.  Performs production in accordance with volume fluctuation, business need, and effective procedures. 

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives.
 

Main Responsibilities:

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.

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

• Utilizes +QDCI boards for Safety issues

• Attends Safety Meetings.

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. 

• Ensures completion of quality documentation (BFR’s, logbooks, etc) accurately in a timely manner.

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

• 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.

• 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.

• Utilizes 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.

Involvement:

• Trains and orients new team members (at any level) as assigned. 

• Follows proper documentation as required by cGMP.

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

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

• Maintains acceptable training as described in key requirements.

• All other duties as assigned.

Context of the job/major challenges

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

• Works with Senior Technicians, leads, and managers to ensure operational area is running as intended to meet all operational goals. 

• Must attend shift change daily to ensure preparedness for work day.

• Completes Real Time SAP transactions on all aspects of Invento