Sanofi Group Director Site Technical Engineering in Swiftwater, Pennsylvania
Director Site Technical Engineering
( Swiftwater, PA) The Technical Engineering Platform Leader is responsible for providing technical engineering oversight with an emphasis on the quality by design of deliverables/content for the engineering activities to support Capex and OpEx Projects and manufacturing areas. Included in this mission is supporting the various phases of design (conceptual, basic, detailed), supporting feasibility studies, ownership of the site's C&Q program, Sterilization Engineering, Sterilization Validation Maintenance and providing technical assistance to Manufacturing, Maintenance, and other site teams.
*The Platform Leader supervises a team of engineering professionals; the Organization chart is communicated in Workday. Working with other site leaders & those within Technical Services and customer/stakeholder groups to manage workload and staff assignments, balancing cost, schedule, resources and priorities to meet business commitments including Quality/Compliance, and safety, health and environmental objectives is expected. Ownership of the department's fiscal budget is required. People development and team development for skills and tools required to meet business needs is mandatory.
*This position requires the incumbent to be competent to provide technical leadership covering a wide variety of process and utility GMP systems, infrastructure, and non-GMP utilities (approx. 80% GMP / 20% non-GMP). This role requires a strong customer-service and team orientation capability. The expectation is to work closely with the Maintenance team to optimize technical solutions and efficiency of service, and to work with customers, Manufacturing Technology, Quality, IS and other stakeholders to assure effective and efficient alignment of scope, priorities and resources. This is a "hands-on" role, with an expectation of engagement, visibility and access by the staff, customer and stakeholder teams. This person will be key to supporting regulatory agency audits as a SME on a variety of topics.
*The incumbent, along with the team members will participate in development of concept, design and fabrication, commissioning and qualification of process and other systems (often in a GMP environment) and will participate with the Manufacturing Technology team in the development and / or technology transfer of new solutions and modifications to our existing manufacturing process systems while adhering to established standards and regulatory compliance requirements. The incumbent is responsible for assuring the development of appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, within budget and schedule commitments, and while optimizing the use of external vs. internal resources. Will share responsibility for department OPEX budget with the Sr. Director, Site Engineering and Site Project Management Platform Leader.
*This is a site role within the Swiftwater Technical Services team. The perimeter includes support for site capex projects with total annual spend of <= $100M/yr. The position is responsible for supervising a team of sub platform leads engineering professionals, with shared OpEx budget responsibility that includes managing contracted staff and specialty consulting services in the range of $5M/yr.
*This role will be accountable for supervising and leading technical engineering delivery including quality and technical content of deliverables for support to a portfolio of site-level & providing technical resources to global level projects and technical assistance to IO and non-IO site operating teams simultaneously. Project performance will be measured at site level by the Industrial Performance team, and the success of the technical support to production (as led by the "FFaST Teams" will be measured by reported performance metrics within Industrial Affairs.
*The expectation for this position is to facilitate and drive timely and sound decisions while strongly collaborating within a team environment of customers, stakeholders and partners.
*B.S. Engineering or a related field, in a discipline relevant to biologicals and/or vaccines manufacturing (eg: Biochemical or Chemical Engineering), or with appropriate supplemental industrial experience.
*5 years’ experience in direct management of people and in a leadership position (I.e. Demonstrated ability to build relationships/partnerships, effectively communicate, interact and collaborate with customers, internal and external team members and business partners is essential.)
*10 years of experience in applied design engineering relevant to biologicals production, with demonstrated breadth of knowledge and experience in related disciplines appropriate to a large mixed-use site. (I.e. Knowledge of GMP requirements and commissioning and qualification is required. Working knowledge of maintenance practices including calibration and reliability engineering. An understanding of cGMP regulatory compliance and industry guidance for aseptic formulation and filling is a must. Demonstrated quality by design and a quality mindset experiences are required. This position requires strong analytical skills (ability to apply engineering principles to design), troubleshooting skills. Technical areas requiring support include: egg processing operations, bacterial fermentation, cell culture, buffer/media preparation, purification/separation, formulation, filling, packaging, clean utilities, HVAC, washing/cleaning/CIP, sterilization, de-contamination & waste handling, Commissioning & Qualification, site utilities and Waste Water Treatment, site infrastructure and facilities, laboratories, and offices.)
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.
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.