Process Engineer

Sanofi; Swiftwater (Monroe County); On-site; USD 90,000 - 120,000; Full time

Job summary

Sanofi is seeking a Process Engineer to join the Engineering & Projects team at the Swiftwater site in PA. You will provide process engineering services to assigned projects and assist on production floor troubleshooting, delivering solutions that meet quality and safety standards.

You will lead SME activities, specify and design process equipment, manage vendors, and develop commissioning/qualification documentation while coordinating with Maintenance, Operations, Quality, and Continuous

Qualifications

• BS in Engineering (Chemical preferred; other 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 and GMP regulatory requirements for pharmaceutical manufacturing and CQ activities.
• Sound organizational, written, and oral communication skills.

Responsibilities

• Provide process engineering services to assigned projects and assist on production floor troubleshooting.
• Act as SME providing support to Manufacturing, Engineering, and Capital Projects on drug substance related projects.
• Develop technically sound process equipment concepts and scope; specify and design process equipment.
• Manage equipment vendors to meet requirements, cost, and schedule.
• Develop and execute commissioning and qualification documentation as required.
• Lead equipment start-ups and optimization activities.
• Collaborate with Maintenance, Operations, Engineering, Quality, and Continuous Improvement teams throughout the design process.
• Ensure knowledge transfer after project completion for ongoing support.

Skills

Process engineering

Troubleshooting

Analytical skills

Cross-functional teamwork

Project management

Education

BS in Engineering (Chemical preferred)

Job description

Job Title: Process Engineer Location: Swiftwater, PA

About the Job

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. 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 be the one to 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 be required to manage a significant number of engineering deliverables and tasks, each with their own deadline. In addition to technical competence, 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. 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.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities

As a Process Engineer, you will be a technical leader who knows their assigned equipment and processes and is passionate about collaboration and problem-solving. You will seek to grow Sanofi’s capability by delivering and supporting process equipment that is optimally suited for the end user.

Key Accountabilities

• 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.

Related KPIs & Metrics

• 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

About You

Basic Qualifications

• Bachelor of Science in Engineering (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

Key Roles (D,A,I)

• 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.

Languages

English: Proficiency in both written and spoken English.

Desired Qualities / Experiences

• 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

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 andwellness 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 affirmatively commit to a 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 Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmatively commit to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affection