Process Engineer; Fill-Finish

Position: Process Engineer (Fill-Finish)
** Job Title**:
Site Schedule

* 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  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.
** Main 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
** About You
**** 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.
** Other Qualities:
*** 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
* Experience with lyophilization, CIP/SIP systems, and filling technologies
* Experience in sterile manufacturing
* Ability to…