Plant Process Commissioning Qualification Engineer

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

Job Title : Plant Process Commissioning Qualification Engineer

• Location: Swiftwater, PA

About the Job

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.

Main 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

This role offers a dynamic blend of technical leadership quality governance and cross functional collaboration.

As a key member of our engineering team, you will

• 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.

Scope and Impact

Your work will directly influence the quality and compliance of engineering documentation across both CAPEX and OPEX projects by applying Global Engineering Guidelines and local engineering methods you will ensure that every project meets the highest standards of engineering and regulatory excellence Specific activities include

• 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

About You

Basic qualifications

• 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.

Additional skills:

• Packaging and Inspection process systems
• Process Equipment Filling systems isolators purification systems
• Chromatography systems autoclaves washers and Controlled Temperature Units
• GMP Utilities WFI Clean Steam Clean Compressed Air
• Experience in the vaccine or pharmaceutical industry
• Demonstrated expertise in the quality review of good documentation practices
• GDP Knowledge of quality and regulatory requirements applicable to pharmaceutical and biotech manufacturing
• Experience with contemporary commissioning and qualification methods

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sanofi US endeavours to make our career center accessible to any and all users.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people …

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$85.500,00 - $123.500,00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.