Process Engineer II – BioProcess Engineering (CMC / GMP Biologics) (contract)
Sanofi, Framingham, MA, United States
Overview
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.
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
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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.
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
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