Sanofi Group Process Engineer Principal in Westborough, Massachusetts

Process Engineer Principal


Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.


The Principal Process Engineer position is part of Process Science in Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston. Global MSAT function within Specialty Care Operations (SCO) assures robustness and economics of cell-culture based manufacturing process in support of SCO products Life Cycle Management Strategy (LCM) by

  • Driving next generation LCM process development and support key SCO strategic initiatives

  • Leading Tech transfer, scale-up development and adaptation, control strategy implementation, process validation, comparability for SCO products introduction at Sanofi and external Industrial sites

  • Owning process control strategy of licensed products and providing technical assistance and partnership to commercial manufacturing and QC at Sanofi and external sites including change assessment, process monitoring, troubleshooting and continuous improvement for drug substance

MSAT-Process Science is the process owner of all industrial manufacturing processes, analytical methods and associated process control strategies for antibodies and antibody-like molecules expressed from mammalian systems.


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Principal Process Engineer will apply her/his solid understanding of engineering principles and professional practices to contribute to MSAT-Process Science mission by performing following duties in one of the Process Science areas

  • Leading technical expert within MSAT in one of the Process Science areas such as Cell-culture, Protein Purification, Filtration, Formulated Drug Substance (with linkage to Drug Product), Process Equipment Technologies, including single use technologies (e.g. filters and membranes) & Validation practices

  • Leads identification of risks and opportunities with existing processes, surveys novel process technologies and PAT tools and manages their evaluation in support of next generation manufacturing process platform design strategy

  • Supports new facility projects in the key skill center in disposables technologies including filters and membranes

  • Leads identification of single use technology based production design and optimization, material identification, comparability assessment and performing quality by design (QbD) for new production process setup

  • Participate as a team member of fit-gap analysis to support sourcing decision and other large CAPEX project

  • Reviews and approve User Requirement documents and supports engineering function in definition of functional specification followed by C&Q for specific unit operations

  • Lead MSAT Process Science representation in the LCM project or Tech Transfer team in support of process design, process control strategy (raw materials, process, methods, equipment), and process validation for next generation process

  • Participates in major troubleshooting task force for complex deviations (non-conformance) in manufacturing and propose corrective actions in their respective expert domain when appropriate

  • Support QC and regulatory teams during health authority audits and prepare for supportive regulatory documents for responses or new filings in her/his expertise areas

  • Reviews and approves technical reports required for regulatory documents

  • Leads harmonization and standardization of process characterization, performance qualification best practices and its implementation for next generation process

  • Provides scientific mentorship to junior staff and collaborates with other scientists/engineers across the biologics network of sites within sanofi and partnership organizations

  • May lead a project team or task force in support of MSAT mission

  • Works under consultive direction towards long range objectives. Independently determines technical strategy for the project. Develops proposal for specific initiatives in line with MSAT mission and influences organization to gain acceptance.


  • Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs



Degree in engineering, engineering management or other relevant discipline


BS and 14 years of professional experience


MS and 10 years of professional experience


PhD and 8 years of professional experience


  • Hands-on experience at Laboratory, pilot or manufacturing scale for biological products

  • Strong skills in data analytics and modeling methods and relevant software

  • Strong experience in one or more areas of process development, process transfer, process scale-up and validation activities

  • Desire strong working experience in material science and biopharma development experience in single use technology area. Contribute material science input for design of experiments and selection of materials (eg filters and membranes etc)

  • Strong knowledge of use of structured methodologies for in one of the areas linked to upstream and/or downstream process design, scale-down model, process control strategies, scale-up, validation and continuous process verification as applied to mammalian-expressed proteins

  • Solid understanding GMP commercial biologic manufacturing operations

  • Strong experience of working in a team environment with other technical staff

  • Excellent scientific background and presentations skills

  • Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams


  • Strives for results – sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets

  • Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization

  • Commit to customers- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization

  • Act for Change – Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes


Domestic and International travel required

Job: Engineering & Maintenance

Primary Location: United States-Massachusetts-Westborough

Job Posting: Oct 27, 2016, 9:59:03 AM

Job Type: Regular

Employee Status: Regular