Plant Process Commissioning Qualification Engineer

Sanofi•Swiftwater, PA

9d•$85,500 - $123,500•Onsite

About The Position

The Plant Process Commissioning Qualification Engineer is a critical engineering quality review and execution support role responsible for the consistent application governance and maintenance of Commissioning and Qualification Engineering platform procedures. In this role, you will apply Commissioning and Qualification testing templates, engineering standards, and specifications across both OPEX and CAPEX projects. You will directly support antigen and filling manufacturing operations with a strong emphasis on Inspection and Packaging processes, work that ultimately protects patients and ensures the integrity of life-saving vaccines and pharmaceutical products. 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 lives.

Requirements

Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Computer sciences or other related technical fields.
5+ years of experience in Commissioning, Qualification, Testing Equipment, quality assurance, Engineering, Packaging or other related fields.
Demonstrated expertise in the quality review of good documentation practices (GDP).
Knowledge of quality and regulatory requirements applicable to pharmaceutical and biotech manufacturing.

Nice To Haves

Packaging and Inspection process systems
Process Equipment
Filling systems
isolators
purification systems
Chromatography systems
autoclaves
washers
Controlled Temperature Units
GMP Utilities
WFI
Clean Steam
Clean Compressed Air
Experience in the vaccine or pharmaceutical industry

Responsibilities

Review and approval of SAT, FAT, Commissioning and Qualification and Design documentation, protocols, test scripts, reports, assessments.
Impact assessments, Change Control, Functional Component and Design Review, Design Qualification (DRDQ).
Protocol and Test Script authoring.
Continuous improvement authoring updates to site Commissioning and Qualification platform procedures.
Engineering Change Management process.
Contractor management.
Serve as the primary Commissioning and Qualification Engineering interface with project management and project controls functions supporting contractor budget and schedule performance measurements and reporting.
Provide strong Commissioning and Qualification focus and oversight for packaging and inspection systems.
Provide Commissioning and Qualification support for projects focusing equipment and utilities to support Drug substance processing, Final Filling process, and Inspection and Packaging.
Review and approve protocols, test scripts, data packs and reports to ensure consistent high-quality engineering documentation across all assigned projects.
Audit engineering quality in accordance with site and project level Commissioning and Qualification plans, development qualification, Global Engineering Guidelines and Quality Operational Qualification Guidelines.
Update and approve site Commissioning and Qualification platform methods and procedures ensuring alignment with project lessons learned, GEG updates and global quality document revisions.
Support technical engineering staff in the use and documentation of the engineering change management process.
Execute audit initiatives and remediation activities including action items resulting from internal and external audits, change controls and deviation remediation as directed by the Plant Process and Commissioning and Qualification Lead and/or Site Project Engineering Lead.
Manage contract associates as required to support Commissioning and Qualification activities.
Executing System and Functional Component Criticality Assessments.
Conducting Design Review and Qualification activities.
Authoring Protocols, Test Scripts and Reports as assigned.
Authoring technical assessments in support of change controls, deviations and CAPA.