Senior Plant Commissioning & Qualification Engineer

Sanofi; Swiftwater (Monroe County); On-site; USD 110,000 - 150,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a Plant Process Commissioning Qualification Engineer to lead the governance and execution of commissioning and qualification activities across OPEX and CAPEX projects in vaccine and biologics operations.

You will develop and approve protocols, test scripts, data packs, and reports, while driving site GMP compliance and continuous improvement through change controls and QA collaboration.

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Computer sciences or related field.
• 5+ years of experience in Commissioning, Qualification, Testing Equipment, quality assurance, Engineering, Packaging or related fields.

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

Skills

Quality review

Documentation management

Cross-functional collaboration

Engineering oversight

Education

Bachelor's degree in Engineering or life sciences

Job description

Sanofi in Swiftwater, PA is seeking a Plant Process Commissioning Qualification Engineer to lead the governance and execution of commissioning and qualification activities across OPEX and CAPEX projects in vaccine and biologics operations.

You will develop and approve protocols, test scripts, data packs, and reports, while driving site GMP compliance and continuous improvement through change controls and QA collaboration.