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Project Engineer IV Project Engineer IV
Ref No.: 17-14570
Location: Swiftwater, Pennsylvania
Process engineer executes process design engineering activities for strategic capital and operational improvement projects within the NA Regional GEM Organization. This position may be required to lead the Process Engineering scope of major capital projects and /or exhibit demonstrated expertise in process technology. In the SO role, the process engineer is considered an expert in the concept, design and fabrication, commissioning and qualification of process systems in a GMP environment.
Interpreting Process and Manufacturing Requirements
Prepare and 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
Make sure engineering contractor calculations are correct and review vendor designs for adherence to specififcation
Responsible for design that meets project budget and schedule
Responsible for developing preliminary and basic engineering deliverables that meet URS and compliance requirements including best practices guidelines
Accountable for technical quality of design
Perform appropriate reviews with stakeholders
Commissioning and qualification
Lead C&Q execution for accountable systems. Participate/assisste in SIA, FCCA, DR/DQ etc. Review C&Q test plans for technical content and lead FAT/SAT for assigned systems.
Support mechancial completion and start-up. Participate and lead FAT and Critical test plan execution
Responsible to understand site specific standards and procedures

Minimum 10 years of experience in applied process design engineering and project experience.
Proven record of working independently within a matrixed project team
Experience in equipment start-up, qualification and/or validation is preferred
Knowledge of unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, downstream operations, formulation, steaming (SIP) and cleaning (CIP)
Knowledge of clean utility design (i.e. WFI, clean steam, clean air and gases systems) is desirable.
Must understand the relationship between Good Manufacturing Practices, industry standards and their application to the manufacturing process
Ability to effectively communicate with internal and external team members.
Strong analytical skills (engineering analysis), hands-on troubleshooting skills and the capability to utilize AutoCAD, analysis software and company quality system software