Process Engineer (Fill-Finish)

Sanofi•Swiftwater, PA

About The Position

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 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 and maintainability and project constraints. 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. About Sanofi: 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.

Requirements

Basic Qualifications Minimum Bachelor of Science, Engineering (Chemical or Mechanical preferred) or related fields.
Minimum 5-+ years of experience in aseptic processing, sterile manufacturing, or fill-finish engineering experience.
Hands on experience with filling equipment and aseptic barriers.
Technical knowledge of drug product processes, and understanding of automated mechanical systems
Strong analytical skills (ability to apply engineering principles to design)
Hands-on engineering troubleshooting skills
Knowledge of GMP (Good Manufacturing Processes) regulatory requirements for manufacturing and CQ activities
Sound organizational, written, and oral communication skills
English: Proficiency in both written and spoken English.

Nice To Haves

Experience with lyophilization, CIP/SIP systems, and filling technologies
Experience in sterile manufacturing
Ability to lead small projects as a project manager
Understanding of the impact of utilities on equipment design and operation
Understanding of cost, schedule, and scope management including progress measurement
Knowledgeable of the automation design and testing processes

Responsibilities

Work as a Subject Matter Expert (SME) providing support to Manufacturing, Engineering, and Capital Projects with a focus on fill-finish-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
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
Comisionan & Qualification (CQ) completion rate
Deviations and discards due to equipment issues

Benefits

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.
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 Affirmative Action employers committed to a culturally inclusive and diverse 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; 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.
North America Applicants Only The salary range for this position is: $100,500.00 - $145,166.66 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 .