Aseptic Production Technician

Job title: Aseptic Production Technician

Location: Swiftwater, PA

Shift: 2nd shift

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.

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:

• Performs production in accordance with volume fluctuation, business need, and effective procedures.

• Ensures all materials required for production are available prior to need. Completes sampling and corresponding documentation as required. Completes move tickets and picklists in an accurate and timely manner to ensure accurate inventory.

• Participates in all aspects of inventory management (SAP, cycle counting, ordering, etc.).

• Identifies all production issues and relays them to the leadership team.

• Works to prepare assigned areas for the oncoming shifts. Completes tasks and corresponding documentation as required by cGMP.

• Works with Senior Technicians and Managers to ensure a smooth operation. May serve as processing room leads and strive to become experts in their assigned areas.

• Completes at least one developmental classes annually focused on one of the four core competencies.

• Completes at least one developmental class outside of the core competencies annually.

• Works to become trained in all assigned training modules.

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

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

• Participates in monthly safety meetings.

• Report 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.

• Works to understand cGMP’s.

• Identifies areas of deficiency to the leadership team and offers potential suggestions for improvements.

• Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product.

• Works with the leadership team to complete deviation investigations and root cause analysis.

• Works to complete quality documentation (BPR’s, logbooks, etc) accurately in a timely manner.

• CFR (code of federal regulations) / PAI inspection readiness.

• FDA audit understanding and awareness.

• Participates in team meetings.

• Actively communicates improvement ideas, issues, concerns, etc to team members.

• Participates in cross functional teams where necessary to complete projects in an effective and timely manner.

• Lead Operator, Completes picklists and move tickets for all tasks completed on any given day. This may require inputting data into SAP, along with entering work orders and reagent orders.

• Ensures proper process area operation by pre and post run set up and maintenance of lab and equipment.

• Recommends changes to BPRs, SOPS and SWIs were warranted. Write and edit documents under supervision.

• Seeks out cross training in other areas whenever possible.

• Responsible for assisting in writing and assisting incident investigations, CAPA's, change controls, along with assisting the higher tech levels and Principle Investigators with projects.

• All other duties as assigned.

About you

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 1+ years in cGMP or Pharmaceutical or any manufacturing experience
• Associate's degree with 6+ months in cGMP or Pharmaceutical or any manufacturing experience
• Bachelor's degree with or without cGMP or Pharmaceutical or any manufacturing experience
• Proficiency in at least but not limited to three areas of operations or product line.
• Must be proficient in at least one of the following areas: Utility Sampling, equipment prep, tank movement OR Must be a qualified trainer in vial wash or debag and SAP
• Must have knowledge and access to systems (SAP, Master, SCADA, RT Reports, Labware) OR Must have knowledge and access to systems (SAP, HMI).
• All other duties as assigned.

Sanofi Pasteur SA and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. …