Process Engineer

Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improve lives. Our team strives to transform the practice of medicine, connecting our science to communities in meaningful ways. Within our Sanofi Manufacturing & Supply Ambition, we’re redefining our strategy, culture, and processes to make a tangible impact worldwide.

About the role

In this role, you'll join the Engineering & Projects team at our Swiftwater site. You will be responsible for providing process engineering services to assigned projects and assisting on production floor troubleshooting assignments. You will determine how user requirements and quality requirements will be satisfied within design solutions that utilize the laws of engineering, mathematics, and physics coupled with process engineering aptitude. You will manage a significant number of engineering deliverables and tasks, each with its own deadline. This position requires the ability to work well in a cross-functional team to accomplish the best technical solution that also considers compliance, safety, operability, maintainability, and project constraints.

Responsibilities

• 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.
• Ensure knowledge transfer at the conclusion of each project to allow for appropriate support of process equipment.
• Undertake routine tasks related to the process equipment area.
• Interface with Operations to ensure the manufacturing process equipment consistently meets production requirements.
• Provide input to quality and safety systems.
• Provide advanced technical support to diagnose and resolve complex system issues, minimizing downtime.
• Identify improvement opportunities for critical process systems.
• Implement process improvements to enhance efficiency, safety, and quality.
• Participate in deviation and root cause investigations as required.
• Provide input on budget and timelines for process activities.
• Communicate issues and resolutions to management, peers, and the engineering team.
• Advise on system lifecycle changes, including upgrades, decommissioning, and revalidation requirements.
• Approve process improvement initiatives.
• Decide on advanced troubleshooting methods and issue resolution strategies.

Key Performance Indicators

• 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.

Requirements

• Bachelor of Science in Engineering (Chemical preferred; other engineering disciplines accepted).
• 4+ years of 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 Practices) regulatory requirements for pharmaceutical industry manufacturing and CQ activities.
• Sound organizational, written, and oral communication skills.
• Proficiency in both written and spoken English.

Desired Qualities

• 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 (Factory Acceptance Testing), SAT (Site Acceptance Testing), and start-up experience.

Benefits

• Supportive, future-focused team with endless opportunities to grow your talent and drive your career, including promotions or lateral moves, at home or internationally.
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
• Opportunity to shape the future of medicine and vaccine delivery with cutting-edge technology.
• Leverage digital, data, and AI-driven innovation to power industry-leading performance.