Impactful Plant Process CQ Engineer for Pharma

Sanofi; Pocono Township (PA); On-site; USD 86,000 - 124,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Career growth opportunities

Job summary

Sanofi is seeking a Plant Process Commissioning Qualification Engineer in Swiftwater, PA to champion governance and execution of commissioning and qualification for manufacturing platforms. You will apply templates and standards across OPEX and CAPEX projects, supporting antigen and filling operations with focus on packaging and inspection processes to ensure patient safety and product integrity.

As a key member of the engineering team, you will author protocols, test scripts and data packs,

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5+ years in commissioning, qualification, testing equipment, quality assurance, engineering, packaging or related fields.
• Experience in the vaccine or pharmaceutical industry and knowledge of good documentation practices.

Responsibilities

• Review and approve SAT FAT commissioning, qualification, design documentation protocols, test scripts, reports and assessments.
• Impact assessments, Change Control, Functional Component and Design Review (DRDQ).
• Protocol and Test Script authoring.
• Continuous improvement by updating site Commissioning and Qualification platform procedures.
• Engineering Change Management, contractor management, and cross-functional collaboration.

Job description

Sanofi is seeking a Plant Process Commissioning Qualification Engineer in Swiftwater, PA to champion governance and execution of commissioning and qualification for manufacturing platforms. You will apply templates and standards across OPEX and CAPEX projects, supporting antigen and filling operations with focus on packaging and inspection processes to ensure patient safety and product integrity.

As a key member of the engineering team, you will author protocols, test scripts and data packs,