Sanofi Group Manager Process Engineering in Swiftwater, Pennsylvania
Manager Process Engineering
Manager Process Engineering
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit:www.sanofipasteur.comorwww.sanofipasteur.us
Sanofi Pasteur SA 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.
The Manager Process Engineering executes process engineering activities for strategic capital projects within the North American Regional GEM Organization. This position is required to manage development concept, design and fabrication, commissioning and qualification of process equipment and systems in a GMP environment. This position is also a participant in the development and / or technology transfer of new solutions and modifications to our existing manufacturing process systems while adhering to established regulatory compliance requirements. The incumbent is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments. The incumbent is accountable for producing a design and then implementing the design (commissioning and qualification) according to GEM best practices.
Interpreting process and manufacturing requirements developed by Manufacturing Technology (15%)
Review process flow diagrams, mass balances and process descriptions including crtical parameters provided by Manufacturing technology. Determine thoroughness to proceed with engineering design. Responsible to understand the process requirements and how they impact the equipment design.
Design Development and specifications (30%)
Responsible for developing preliminary and basic engineering deliverables that meet URS and compliance requirements including best practices guidelines. Depending on project, some deliverables may be generated internally while other times by external engineering. Accountable for technical quality of design. Perform appropriate reviews with stakeholders. Make sure engineering contractor calculations are correct and review vendor designs for adherence to specififcation. Participate in PTI reviews. Responsible for design that meets project budget and schedule.
Commissioning and qualification (30%)
Lead C&Q execution for accountable systems. Participate in SLA and FCCA. Review C&Q test plans for technical content. Support mechancial completion and start-up. Participate and lead FAT and Critical test plan execution.
Technical engineering support to manufacturing sites (15%)
Provide technical guidance to site engineering teams upon request. Apply lessons learned from other sites to help with trouble shooting, design issues and testing specifics. Responsible to understand site specific standards and procedures.
Participate in global networks (10%)
Contribute lessons learned to the network. Participate in global initiatives when requested. Responsible to understand current global design guidelines and application.
Scope and Dimensions:
Breadth of responsibility (global/regional/country/site):
Regional responsibility. No budget responsibilities. May manage several contractors and be responsible for accuracy of timesheets and quality of work.
Key dimensions: headcount (direct and indirect) budget,doses, Capex… - Key indicators on which the job holder will be evaluated
Engineer will support CAPEX funded projects for large strategic projects and bundled site projects. Performance is primarily based on ability to meet requirements of project execution and work effectively on multi functional teams.
Freedom to act, level of autonomy :
- Engineer will report to project manager and technical platform leaders. Deliverables will be supervised by project manager and technical platform leader.
The ability to effectively communicate with internal and external team members is essential. This position requires strong analytical skills (engineering analysis), hands-on troubleshooting skills and the capability to utilize AutoCAD, analysis software and company quality system software.
B.S., Chemical Engineering.
5 years of experience in applied process design engineering and project experience are required - this includes experience with:
Unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, downstream operations, formulation, steaming (SIP) and cleaning (CIP).
Good Manufacturing Practices, industry standards and their application to the manufacturing process.
AutoCAD analysis software
Experience in equipment start-up, qualification and/or validation
Knowledge of clean utility design such as WFI, clean steam and clean air systems is desirable.
Ability to work effectively on a team
Customer commitment (meet commitments).
Job: Engineering & Maintenance
Primary Location: United States-Pennsylvania-Swiftwater
Job Posting: Aug 24, 2016, 3:03:39 PM
Job Type: Regular
Employee Status: Regular