Process Engineer

• Work as a Subject Matter Expert (SME) providing support to Manufacturing, Engineering, and Capital Projects with a focus on drug substance related projects

• Assist and develop technically sound process equipment concepts and scope

• Specify and design process equipment

• Manage equipment vendors as required to meet requirements, cost, and schedule

• Develop and execute commissioning and qualification documentation as required

• Actively manage equipment start-ups and optimization

• Involve site Maintenance, Operations, Engineering, Quality, and Continuous Improvement teams throughout the design process

• At the conclusion of each project, ensure knowledge transfer to allow for appropriate support of process equipment.

• Undertaking routine tasks related to the process equipment area

• Training and development

• Interface with Operations to ensure the manufacturing process equipment consistently meets production requirements

• Provide input to quality and safety systems

• Providing advanced technical support to diagnose and resolve complex system issues, minimizing downtime

• Identifying improvement opportunities for critical process systems

• Implementing process improvements to enhance efficiency, safety, and quality

• Compliance (deviations, Corrective Action Preventive Action (CAPA), change control, training)

• Work order metrics

• Commissioning & Qualification (CQ) completion rate

• Deviations and discards due to equipment issues

• Bachelor of Science in

(Chemical preferred; other engineering disciplines accepted)

• 4+ years process engineering experience relevant to life sciences and/or vaccine manufacturing.

• Technical knowledge of drug substance processes with a focus on process equipment, understanding of automated mechanical systems, and instrumentation.

• Strong analytical skills (ability to apply engineering principles to design)

• Hands-on troubleshooting skills.

• Knowledge of pharmaceutical processes.

• Knowledge of GMP (Good Manufacturing Processes) regulatory requirements for pharmaceutical industry manufacturing and CQ activities

• Sound organizational, written, and oral communication skills

• Approve: Participate in deviation and root cause investigations as required​.
• Inform: Provide input on budget and timelines for process activities.
• Decide: Communicate issues and resolutions to management, peers and engineering team.
• Approve: Advise on system lifecycle changes, including upgrades, decommissioning, and revalidation requirements.
• Approve: Process Improvement Initiatives
• Decide: Decide on advanced troubleshooting methods and issue resolution strategies.

• English: Proficiency in both written and spoken English.

• Ability to lead small projects as a project manager
• Ability to be an equipment system lead
• Understanding of the impact of utilities on equipment design and operation
• Understanding of cost, schedule, and scope management
• Knowledgeable of automation design and testing processes
• Equipment FAT, SAT, and start up experience

• 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.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

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.

#GD-SP #LI-SP #VHD