Process Engineer IV
Sanofi
Job Title: Process Engineer IV
Location: Framingham, MA
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
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.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
The Process Engineer IV role is expected to
- Provide technical leadership in area of responsibility. Provide technical/scientific support, expertise, and guidance to manufacturing and quality.
- Ensure a solid understanding of engineering principles and theories in the area of responsibility and uses them to solve a range of complex problems in creative and practical ways.
- Lead technical project team or cross-functional team between groups/organizations. Provide input and coordinates support from process development teams.
- Review manufacturing processes and/or development and production data.
- Design and conduct necessary experiments; contributes to understanding and interpretation of results; recommend changes or additional experiments.
- Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
- Provide CMC support and guidance for product life cycle management.
- Attend trainings and scientific meetings to remain current with technology and regulatory guidelines.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
About You
Basic Qualifications
- Bachelor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 7 years of relevant experience in the biopharmaceutical or pharmaceutical related industry – required.
- Master’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 5 years of relevant experience in the biopharmaceutical or pharmaceutical related industry or Doctor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 2 years of relevant experience in the biopharmaceutical or pharmaceutical related industry – preferred.
- Experience with biologics downstream unit operations – required.
Preferred Qualifications
- Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.
- Understand cGMP concept and familiar with quality and regulatory framework.
- Proficient in process data analytics
- Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, Process Data Historian, LIMS, and MES.
- Experience leading projects and/or 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.
Why Choose Us
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
