Senior Process Engineers (cGMP – BioPharmaceutical) JD816695
Providence, RI and MA areas
DPS is looking for multiple (3+) talented and experienced Senior Process Engineers and intermediate-level Process Engineers with strong understandings of the engineering lifecycle related to Biologics Process Equipment design and commissioning/start-up expertise. The ideal candidate should have strong understanding around the design of upstream and downstream process equipment.
• Review Engineering design submissions, technical documents, and provide review comments as per cGMP and Good Engineering Practice (GEP).
• Oversee Client side design of upstream/downstream process equipment projects (the successful candidate must have prior process equipment design expertise) i.e. bioreactors, chromatography and TFF purification skids. Some or all of these systems is desired.
• Must be able to verify process equipment design calculations from third party vendors for process equipment i.e. identify design errors and actively work to resolve.
• Manage and coordinate deliverables from third party design vendors.
• Author/review engineering documentation and technical specifications related to process equipment as defined by Client.
• Start-up troubleshooting and commissioning of process equipment. Must be able to troubleshoot start-up issues.
• Should understand how DeltaV integrates with the equipment mechanically from a commissioning perspective.
• Provide knowledge and expertise for process equipment, utilities and facility design-related projects not limited to Upstream, Downstream processes, CIP, SIP, WFI systems, and other shared services process utilities.
• Demonstrated understanding of fermenters, bioreactors, centrifuges, UF/DF skids, viral filtration, chromatography, and other Biotech/Pharma process equipment. Some or all of this equipment expertise is desired.
• Bachelor's degree in Chemical or Mechanical Engineering.
• Must have a background in equipment design for the biologics sector.
• 7+ years of process engineering experience involving: API, cell culture, upstream and downstream purification, single-use technology, and multiple-use technology.
• Previous experience working in the Biotech/Pharma industry.
• Strongly motivated, well-organized, and shows professional initiative.
• Takes ownership of assignments, can work both independently and as part of the team.
• Ability to work in a fast-paced and challenging environments.
• Excellent organization skills with the ability to manage multiple tasks simultaneously.
• Must be able to communicate and lead people effectively.