Process Mechanical Engineer

Job Title: Process Mechanical Engineer

Location: Swiftwater, PA

About the Job

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.

Overview

In this role, you'll join the Engineering & Projects team at our Swiftwater site.  You will be responsible for providing engineering 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 mechanical 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

As a Process Mechanical 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. 

• Acting as a Subject Matter Expert (SME) and providing support to Manufacturing, Engineering, and Capital Projects

• • Lead and develop technically sound process equipment concepts and scope

  • Specify and design 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 SME 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

Key Involvement in Decision-Making Process:

• 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.

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

Education & Experience & Certifications:

• 4+ years of experience in engineering.

• • Technical knowledge of process equipment, understanding of automated mechanical systems and the ability to create and interpret technical documentation.  

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

  • Hands-on troubleshooting skills

  • The capability to utilize software for design, analysis, and organization. 

• In depth knowledge of pharmaceutical processes.

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

• Sound organizational, written, and oral communication skills.

Desired Qualities / Experiences:

• Subject matter expertise in process equipment used in egg-based and cell culture drug substance manufacturing

• Knowledgeable of the engineering design process

• Understanding of the impact of utilities on equipment design and operation

• Understanding of designing for safety

• Understanding of cost, schedule, and scope management including progress measurement

• Knowledgeable of the automation design and testing processes

Education:

• Minimum Bachelor of Science, Engineering (Chemical or Mechanical preferred) or equivalent. 

Languages:

• English: Proficiency in both written and spoken English.

Why Choose Us?

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.​

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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:

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.