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Sanofi Group Process Engineer IV in Framingham, Massachusetts

DEPARTMENT DESCRIPTION:

Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

  • Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement.

  • Anticipate, respond to, and permanently resolve issues that arise during production.

  • Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.

  • Lead the creation and use of digital process data analytic systems.

  • Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Key Responsibilities:

  • Provide technical support to end-to-end process life cycle from late-stage development, product launch, commercial production, and post-approval lifecycle initiatives.

  • Perform process data monitoring, advanced data analytics, and on-the-floor investigation to anticipate, respond to, and permanently resolve issues that arise during production.

  • Ensure in-depth understanding of engineering principles and theories and uses them to solve a range of complex problems in creative and practical ways.

  • Review development and manufacturing process data. Lead complex investigation of the upstream manufacturing process.

  • Design experiments, interpret of results, draw conclusions, and recommend changes.

  • Lead/support upstream technology transfers, PPQ campaign, and regulatory filing, and change control processes.

  • Lead collaboration with process development department. Provide CMC support and guidance for product life cycle management.

  • Support documentation preparation for regulatory purposes and stay current on regulatory requirements.

  • Lead cross-functional project teams with broad reach, including members from development, manufacturing, quality, engineering, regulatory departments, and external partners to advance critical objectives.

  • Provide technical guidance and train less experienced staff.

  • Maintain and demonstrates knowledge of state-of-the-art principles and theories in their area of responsibility. Initiate/lead new technology evaluation and implementation in commercial manufacturing process.

  • Attend trainings and scientific meetings to remain current with technology and regulatory guidelines.

BASIC QUALIFICATIONS:

  • Bachelor’s Degree in Chemical or Biochemical Engineering, or a similar engineering discipline with 7 years of bio/pharmaceutical industry experience

OR

  • Master’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 5 years of bio/pharmaceutical industry experience

OR

  • Doctor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 2 years of bio/pharmaceutical industry experience

AND

  • Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.

  • Experience with biologics upstream or downstream unit operations.

  • Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

PREFERRED QUALIFICATIONS:

  • Experience with upstream process development.

  • Understand cGMP concept and familiar with quality and regulatory framework.

  • Proficient in process data analytics. Knowledge of cloud computing.

  • Solid understanding of computerized systems in biopharmaceutical manufacturing environment, i.e., LIMS, Distributed Control System, Process Data Historian, and MES.

  • Experience leading projects and cross functional teams.

  • Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

  • Ability to navigate ambiguous circumstance to meet final objectives.

  • Strong communication and technical writing skills. Experience communicating with business partners and senior management.

SPECIAL WORKING CONDITIONS:

  • Ability to gown and gain entry to manufacturing areas.

Sanofi Inc. 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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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