Process Engineer 2, Visual Inspection
About The Position
The Process Engineer 2 that supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection] provides engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plant efficiency and reliability. This role also utilizes their experience with automated systems related to inspection of pharmaceutical products and camera and vision-based inspection systems.
Requirements
- Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 2 years of Engineering experience; or Master’s degree in Chemical or Biotechnology Engineering with no prior experience
- Experience in a Life Science or other regulated industry
- Experience with Engineering drawings and using Quality Systems (e.g., deviation management, change control, CAPA, document management system)
Nice To Haves
- Prior experience working in a cGMP environment or other highly regulated industry
- Experience working in at least one unit operation in a pharmaceutical or Life Science environment
- Prior experience with mammalian cell culture processes
Responsibilities
- Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
- Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
- Develops and aligns basic plans and provides mitigations, as needed
- Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
- Provides direction to detailed design activities in partnership with the EPCM provider
- Writes User Requirements Specifications (URSs)
- Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
- Serves as on-call support for process equipment
- Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
- Performs system impact assessments and quality risk assessments for process equipment
- Performs technology transfer (TT) activities related to process equipment
- Supports execution of Good Manufacturing Practices (GMP) runs
- Provides technical support for root cause analysis (RCA) and process deviation investigations
- Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
- Makes decisions regarding technical risk assessments for new manufacturing equipment
- Provides on-floor manufacturing support for equipment issues
- Provides process equipment training and consultation on topics within assigned area
- Supports continuous improvement projects in partnership with Maintenance and Manufacturing
- Cross-trains on multiple unit operations to assist team with achieving deliverables
- Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
- Other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
