Process Engineer II – BioProcess Engineering (CMC / GMP Biologics)
Schedule: 8:00 AM – 5:00 PM, Mon–Fri (flexible earlier start allowed)
Hybrid: 3 days onsite (flexible which days)
Location: Framingham, MA
Contract: 12 months with potential for extension
Position Overview
Sanofi’s FLEXT Direct program is seeking a Process Engineer II to support the BioProcess Engineering (BPE) team within Global CMC Development. This role supports technology transfer, GMP manufacturing operations, and process data management across a global biologics network, with a strong emphasis on data integrity, documentation, and digitalization, The ideal candidate is detail-oriented, organized, and comfortable working in a cross-functional GMP environment supporting CMC development and manufacturing operations.
Key Responsibilities
- Support technology transfer activities by ensuring accurate collection, structuring, and maintenance of process data, batch records, and technical documentation throughout execution
- Perform data verification, reconciliation, and integrity checks to ensure accuracy, traceability, and compliance for technical and regulatory use
- Maintain and update process trackers, dashboards, and documentation systems to monitor transfer milestones and readiness activities
- Conduct data trending and analysis to monitor process performance, identify anomalies, and support continuous improvement initiatives
- Assist in preparing technical reports, gap assessments, summaries, presentations, and cross-functional updates
- Support deviation and investigation activities by compiling relevant process data and coordinating inputs across teams
- Develop and maintain Excel-based trackers, dashboards, and reporting tools to improve visibility of project status and process metrics
- Collaborate with Manufacturing, Quality, CMC, Regulatory, and Supply Chain teams to ensure alignment and clear communication of data insights
Basic Qualifications
- Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, or related life sciences field with 2–4 years of experience, OR Master’s degree with 1–2 years of relevant experience
- Familiarity with bioprocessing operations (upstream and/or downstream)
- Exposure to GMP manufacturing, laboratory, or quality environments
- Strong proficiency in Microsoft Excel for data tracking, trending, and analysis
- Strong attention to detail with ability to manage multiple priorities and deadlines
- Experience with technical documentation (batch records, reports, logs)
- Basic understanding of data integrity principles and structured documentation practices
Preferred Qualifications
- Experience with technology transfer, process validation, or MSAT activities
- Familiarity with quality systems (deviations, CAPA, change control)
- Exposure to biologics manufacturing or CDMO environments
- Experience with data visualization tools (Power BI or similar)
- Familiarity with structured data or controlled documentation systems
- Exposure to tools such as Unicorn (not required)
- Experience working in cross-functional, fast-paced environments
Additional Information
- Ability to support flexible hours based on manufacturing schedules and cross-site coordination
- Ability to work in GMP manufacturing areas, including gowning requirements when needed
- Hybrid flexibility depending on team needs and project phase