Process Engineer

Sanofi; Pocono Township (PA); On-site; USD 86,000 - 124,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a Process Engineer to provide engineering services for assigned projects and support on production floor troubleshooting. You will determine how user and quality requirements are satisfied within design solutions using engineering, mathematics and physics.

You will manage multiple deliverables, work with cross-functional teams (Maintenance, Operations, Quality, Capital Projects) and drive process equipment improvements, commissioning, qualification, and

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 focus on process equipment, instrumentation.
• Strong analytical skills and ability to apply engineering principles to design.
• Hands-on troubleshooting skills.
• Knowledge of pharmaceutical processes and GMP requirements.
• Knowledge of CQ activities and regulatory expectations.
• Good written and oral communication skills.

Responsibilities

• Act as SME supporting Manufacturing, Engineering, and Capital Projects on drug substance projects.
• Develop technically sound process equipment concepts and scope.
• Specify and design process equipment.
• Manage equipment vendors to meet requirements, cost, and schedule.
• Develop commissioning and qualification documentation.
• Lead equipment start-ups and optimization.
• Coordinate with Maintenance, Operations, Engineering, Quality and CI.
• Ensure knowledge transfer for ongoing support after project.
• Undertaking routine tasks related to process equipment area.
• Provide training and development.
• Interface with Operations to ensure production requirements are met.
• Provide input to quality and safety systems.
• Offer advanced technical support to diagnose and resolve complex issues.
• Identify improvement opportunities for critical process systems.
• Implement process improvements for efficiency, safety, and quality.

Skills

Process engineering

Troubleshooting

Cross-functional collaboration

Automation design

Quality systems

Education

Bachelor of Science in Engineering

Chemical engineering preferred

Tools

Process equipment design

CQ/Change control

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.

• 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

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 Aff ...

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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 ...

North America Applicants Only

The salary range for this position is:

$85.500,00 - $123.500,00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.