Process Engineer

Job Title: Process Engineer

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.

As a Process Engineer, you will ensure robust investigation processes and manage compliance and GXP manufacturing processes. You will lead deviation investigations, manage CAPA implementation, and drive continuous improvement initiatives.

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:

• Promote safe work habits and adhere to safety procedures.

• Lead and perform investigations, CAPAs, and Change Controls (CCRs).

• Provide guidance to drive complex investigation closeouts and implement corrective actions.

• Identify and resolve manufacturing issues to improve processes.

• Represent the team on cross-functional projects for new or updated quality systems.

• Perform trend and statistical analysis to identify improvement opportunities.

• Lead continuous improvement projects with various departments.

• Support regulatory inspections and audits.

• Ensure timely completion of investigations and CAPAs.

• Propose continuous improvements to enhance efficiency.

About You

Basic Qualifications:

• Bachelor's degree in Sciences, Technical, Engineering, or related field.

• 8 years of experience in a cGXP manufacturing environment (or 3 years with a Master’s degree).

• Experience in troubleshooting, investigation, and root cause analysis in a cGMP environment.

• Proficiency in critical thinking and technical writing.

• Knowledge of pharmaceutical API products, GMP, validation principles, and regulations.

• Experience with Quality Management Systems and enterprise systems (LIMS, SAP, OSI/PI, EMS, BMS).

• Strong communication skills and ability to coach and train employees.

Preferred Qualifications:

• Experience in Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.

• Project management and supervisory experience.

Special Working Conditions:

• Ability to gown and access manufacturing areas.

• Occasionally work off-shift hours to support product release.

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 <