Job at a glance
Job Title: Production Technician Location: Swiftwater, PA Shif t: 3rd shift About the Job The Production Technician – Vaccine is responsible for supporting all aspects of the visual inspection production process in compliance with cGMP standards. This role requires strong mechanical aptitude, attention to detail, and a commitment to quality, safety, and continuous improvement. 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: Responsibilities include, but are not limited to: Safety Participates in monthly safety meetings. Reports all safety issues, concerns, incidents, and near misses to team leadership.
Understands how to work the SRR system. Works with the safety and leadership team to provide input on potential safety issues, contribute ideas, and implement all safety initiatives by actively communicating them and helping others understand. Works with the safety team to ensure resources required to address safety issues are secured in a timely manner and that effective resolutions are put in place and trained upon.
Quality Maintains FDA audit understanding and awareness; ensures processes in assigned areas follow proper procedures at all times. Responsible for verifying qualification status prior to performing any task; immediately notifies management if assigned a task for which they are not qualified. Identifies and reports any variation from standard operating procedures. Participates in variance from SOP and incident investigations as required.
Ensures completion and review of quality documentation (BRs, logbooks, etc.) accurately and in real-time. Ensures strict adherence to ALCOA documentation requirements. Follows proper documentation practices as required by cGMP. Understands the function of the quality group. Writes, edits, and reviews process documentation for completeness. Identifies areas of deficiency and offers suggestions for improvements.
Delivery Responsible for execution of all required tasks including: zone 1, zone 2, bench inspection, cap check, stopper check, and relief. Gains and maintains manual bench inspection qualification; notifies management of failure to qualify or loss of qualification. Gains and maintains qualification on all automated inspection processes. Gains and maintains qualification in all zone 1 activities. Participates in delivery and reconciliation with QC.
Ensures the completion of sampling and corresponding documentation as required. Performs sample delivery on site. Ensures all data generation via EBR and iSHIFT is performed in real-time. Gains initial access and maintains proficiency in EBR and iSHIFT. Cost Participates in all aspects of the production process and maintains access to required systems. Examples include: EBR Data Entry iSHIFT (S4HANA) Transactions LIMs Labware (Citrix/WARP) OpsTrakker (MIRA2 & MIRA4) HMI/Network Access Qualipso Actively communicates improvement ideas, issues, and concerns to management along with proposing solutions.
Performs continuous monitoring of reject rates. Works to resolve common production issues related to area of work. Involvement Maintains qualification in all assigned training modules. Maintains a target of 95–100% completion rate on all assigned e-learnings. Trains and orients new team members (at any level) as assigned; maintains qualified trainer status if applicable. Participates in team meetings; demonstrates respect, professionalism, and confidentiality.
Maintains required materials throughout production processes. Has a thorough working knowledge of cGMPs and works to help others understand. Involved in at least one cross-functional team to complete projects e