System Process Engineer SME, Continuous Improvement Inspection – Sanofi - Vaccine

Location: Swiftwater, PA

Who You Are:

The System Process Engineer SME for Inspection Continuous Improvement provides on the shop floor support for the equipment, processes, and projects. This position will strive to Continuously improve the equipment reliabilities and performance in Inspection to improve OEE and reduce reject rate. This position will function as the main interface between Inspection Operations and the Technical Community (especially Engineering/Maintenance/Process Technical (P-tech)/Automation and ITS). This position has no direct reports.

Where We Are:

Swiftwater is located in Monroe County, Pennsylvania about 90 miles west of New York and less than 12 miles from the New Jersey Border. The Swiftwater site is Sanofi’s US headquarters shared by Commercial Operations, R&D, Regulatory Affairs and the Industrial Operation teams. The 500-plus acre campus consists of 40 buildings and 12 modular buildings, housing more than 3,000 employees, including nearly 1,850 employees in Industrial Operations. The Site is located in the beautiful Pocono Mountains, affordable Northeastern Pennsylvania with convenient highway access.

Job Highlights:

• Manufacturing and Supply: Accountable for the daily equipment and processes in Inspection are functioning properly.

• Innovation and Continuous Improvement: Drives continuous improvement through formal projects and process technical improvements to increase OEE, reduce reject rate and downtime due to equipment failures. Implements innovative ways of working and project management best practices. Integrates knowledge in Lean manufacturing, and operations in the design and implementation of “lean by design” projects.

• Serves as a member of the FFIP Continuous Improvement Team and works cross-functionally to respect needs of business partners within Manufacturing, Materials Management, Quality, Manufacturing Technology, Manufacturing Excellence, ITS and Technical Services.

Key Accountability:

• On the shop floor support for equipment and processes to reduce reject rate and improve OEE

• Provide support for projects, especially for time intensive and major projects.

• Provides Technical support for component and equipment qualification, OEE improvement, and general Inspection improvements.

• Providing technical coaching, training and guidance to inspection managers, maintenance personnel and junior engineers on inspection equipment and processes.

• Review/approve process design specifications, technical documents, validation project plans and assist on the execution of equipment validation.

• Ensure efficient and effective operation by creating a proactive environment, developing & monitoring metrics, and communicating with both team members and support functions about operations performance. Utilizing the "+QDCI" Visual Management Systems and Working with the FFIP Management Committee to drive improvements in key metrics.

• Provide people and team development for increased company value and personal satisfaction. Work with department teams to ensure success and encourage collaboration and networking across all functions.

• Ensure compliance with all regulatory requirements and good documentation practices are followed to provide a safe, quality, and effective product.

• Leading tactical responses to equipment related deviations, Agency observations, delivering technical solutions and communicating outcomes to site management.

BASIC QUALIFICATIONS:

• BS in Life Sciences, Engineering, or equivalent experience.

• 8+ years of combined pharmaceutical manufacturing, maintenance, or engineering experience.

• The individual should have worked with Operations personnel for at least 4 years in a technical position with increasing levels of responsibility and have a good understanding of current GMP/GLP, Continuous Improvement methodologies, and common issues addressed to achieve Operational Excellence.

• Must have excellent written and verbal communication skills, as well as the ability to actively, and cooperatively influence and work with cross functional teams.

PREFERRED QUALIFICATIONS:

• Minimum of 5+ years responsibility of technical experience supporting equipment in a Pharmaceutical industrial environment.

• Formulation, Filling and Inspection operations or technical background.

• TERMS OF EMPLOYMENT:

• Approximately 5-15% travel for site visits, vendor relationship management, technical visits (FAT), conferences, and training.

The company believes that facilitating cross-functional development of its employees is extremely important. While posting a job internally does not guarantee that an internal candidate will be selected for the position, it does bring transparency to the hiring process and allows interested employees to inquire about or apply for the position.

Employees are encouraged to pursue their career interests within their own departments and also to consider opportunities in other departments. Employees are encouraged to consider opportunities in different departments where they can utilize their transferable skills. The company supports its hiring managers sourcing and considering qualified employees for open requisitions. The company equally supports managers who consider the long-term needs of the organization and of its employees by fostering internal talent movement. In this way, the company can help retain and develop its most valuable resources, its people.

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.

#GD-SP
#LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.