Process Engineer II – BioProcess Engineering; CMC​/GMP Biologics

Process Engineer II – Bio Process 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

Sanofi’s FLEXT Direct program is seeking a Process Engineer II to support the Bio Process 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.

• 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

• 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

• 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

• 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