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Sanofi Group Filling Operations Shift Owner-Swiftwater, PA - Vaccine in Swiftwater, Pennsylvania

The Filling Operations Shift Leader is responsible for the production activities in B57 Filling, which comprises of 3 Filling Lines and a span of control between 55-65 FTEs on an assigned shift.

Supervises and leads a group of managers (shop floor managers), Principal Investigator (PI) Managers or PIs and operators within a given shift to ensure that the manufacturing activities are carried out with the highest levels of quality, productivity and safety in accordance with Sanofi Pasteur’s guidelines.

RESPONSIBILITIES:

This is a 2nd shift position

  • Responsible of a Perimeter (Filling and Component Prep) and Team

  • In charge of all production, maintenance and quality activities for a given area during a shift.

  • Ensures the delivery of production outputs to the defined capacity plans in respect of quality, performance, cost and HSE standards and regulations.

  • Is responsible for overseeing and leading teams through continuous improvement standards and is responsible for implementing & piloting operational excellence standards for his/her perimeter. Is interfacing with production support functions (such as quality, maintenance, HSE, logistics, CI and MTECH).

  • Leads and/or supports manufacturing functions during day to day operations on a shift. Using Sanofi Manufacturing Systems (SMS) standards manages performance of manufacturing operations to assure production is carried out in a controlled compliant manner. Plans the necessary resources for right execution of the perimeter output

  • Track shift production output and hourly losses and drive continuous improvement countermeasures for decreased performance to assure OEE targets are met or exceeded.

  • Ensures materials for production activities are available and released in order to prevent production delays and lost time.

  • Review planning schedule ahead and ensure all needed resources are aligned.Monitor employee presence and drives Absenteeism management process withHR.

  • Complete Process Confirmation and coaching of Managers & Shift Line Leads to promote a culture of continuous improvement and feedback.

  • Involved in escalation process to provide support for production issues by partnering with support functions and technical staff.

  • Builds development plan for the team to support business needs.

  • Mange recruitment process & staffing or short-term contract within the shift in partnership with Business Systems and HR.

  • Identify recurrent problems and initiate Root Cause Problem Solving on the Shop Floor.

  • Provides direction for and assists with development of area Production Managers.

  • Provide leadership and mentoring at the GEMBA to develop technicians and identify high potentials to be developed into management roles.

  • Actively mentors Managers through coaching and day to day interactions.

  • Exemplifies LEAD competencies and is a role model of Quality, Respect, Integrity and Teamwork.

  • Investigate and approve quality deviations in Phenix, propose and implement Mitigation Plans, Corrective Actions and Preventive Actions to address Root Cause of events.

  • Meets all deliverables within the established cycle time.

  • Participate in GPS initiatives & drive CI action follow up.

  • Develop disciplinary and behavioral standards for employees in collaboration with HR.

Aseptic Filling is a high pace critical operation with multiple cross functional interaction points.

THE KEY ASPECTS OF THE JOBS INCLUDE:

  • Providing high quality vaccines per Sanofi and Regulator’s standard for sterile injectables.

  • Manage the hourly losses for all the Filling Lines and assure aggressive targets of production are maintained in order to meet the business objectives.

  • Deliver 100M vaccine doses per year within established cycle times to meet or exceed time to market standards and improve market access.

EDUCATION/EXPERIENCE:

Basic Qualification

  • 7+ years’ experience in a cGMP Aseptic manufacturing environment

  • 3+ years leading teams

  • Bachelor’s Degree in Life Sciences (e.g. Biology, Chemistry, Biochemistry) or Engineering (e.g. Chemical Engineering) preferred

  • Strong understanding of Quality systems

Preferred Qualifications

  • Experience in an Aseptic manufacturing (cGMP) environment.

  • Experience in managing multiple priorities in production environment and provide support to meet the manufacturing schedule while maintaining quality and compliance.

  • Experience in inspections conducted by external regulators.

  • Experience working with cross-functional teams, including Quality, Manufacturing Technical

  • Services, Facilities, Engineering and Validation.

  • Experience reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

  • Experience troubleshooting, investigation (GPS), root cause and risk analysis in a cGMP environment.

  • Ability to effectively and appropriately escalate operational issues.

Special Working Conditions

  • Ability to gown for entry to Aseptic manufacturing areas.

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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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.

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