Plant Process CQ Engineer — Commissioning & QA

Sanofi; Pennsylvania, United States, Northern America, Americas; Hybrid; USD 110,000 - 150,000; Full time

Job summary

Sanofi is seeking a Plant Process Commissioning Qualification Engineer in Swiftwater, PA. The role focuses on governance and execution of commissioning and qualification procedures across OPEX and CAPEX projects, directly supporting antigen and filling manufacturing operations, packaging, and inspection systems to ensure GMP compliance and patient safety.

The engineer will review, author, and approve protocols and related data packs, drive continuous improvements, and manage contractor staff as

Qualifications

• Bachelor's degree in a related technical field.
• 5+ years of experience in commissioning, qualification, testing equipment, quality assurance, engineering or related fields.
• Experience with pharmaceutical manufacturing processes and GMP.

Responsibilities

• Review and approve SAT FAT commissioning, qualification, and design documentation.
• Lead protocol and test script authoring.
• Support change control and design reviews (DR/DQ).
• Audit quality and ensure regulatory alignment with site and project plans.
• Manage contractor performance and project controls as needed.

Skills

Commissioning & Qualification

Quality Assurance

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in engineering/related technical field

Job description

Sanofi is seeking a Plant Process Commissioning Qualification Engineer in Swiftwater, PA. The role focuses on governance and execution of commissioning and qualification procedures across OPEX and CAPEX projects, directly supporting antigen and filling manufacturing operations, packaging, and inspection systems to ensure GMP compliance and patient safety.

The engineer will review, author, and approve protocols and related data packs, drive continuous improvements, and manage contractor staff as