Senior Process Engineer - Life Sciences

Current job opportunities are posted here as they become available.

Job:
Senior Process Engineer – Life Sciences

GBA is seeking a Senior Process Engineer to lead facility design efforts for biopharmaceutical and drug product manufacturing clients across a broad range of sectors and modalities such as sterile fill/finish and aseptic processing, biologics and animal health, API, and cell and gene therapy. In this role, you will serve as a technical leader and trusted client partner, guiding projects from early feasibility through construction while mentoring junior staff and contributing to GBA's growth as a recognized leader in life sciences A&E consulting.

This is an opportunity to apply deep process engineering expertise to work that matters and with a team that is committed to your continued development.

Candidates may bring specialized expertise in one or more manufacturing modalities, including but not limited to: sterile fill/finish, biologics upstream/downstream processing, API synthesis, cell and gene therapy, or oral solid dosage. The successful candidate will lead and execute technical design work, mentor junior engineers, and contribute to business development initiatives across GBA’s growing Life Sciences portfolio.

• Lead, manage, and/or execute process engineering design efforts at all project phases, from feasibility through construction
• Develop process operating strategies for throughput, compliance, and operability and leads process discovery workshops
• Mentor junior engineers and contribute to professional development initiatives
• Generates design documentation including PFDs, P&IDs, piping layouts, and equipment specifications
• Perform equipment sizing, mass/energy balances, and engineering calculations
• Coordinate cross-disciplinary teams and delegate tasks to junior engineers
• Apply in-depth knowledge and provide technical leadership for one or more biopharmaceutical manufacturing modalities, such as:
  • Sterile fill/finish and aseptic processing (vial, syringe, cartridge, bag filling; lyophilization; isolator/RABS)
  • Biologics manufacturing (bioreactor systems, cell culture, fermentation, upstream and downstream processing)
  • API manufacturing (small molecule synthesis, peptide production, purification)
  • Cell and gene therapy manufacturing (viral vector production, ex vivo cell processing)
  • Oral solid dosage or other solid dose manufacturing
• Facilitates design reviews and decision workshops and builds client alignment on requirements and tradeoffs.
• Engage with clients through workshops, field investigations, and technical documentation
• Support marketing efforts and proposal development
• Conduct feasibility studies, process simulations, and risk assessments
• Mentor junior engineers and contribute to professional development initiatives

• Bachelor’s degree in Chemical Engineering or a related field AND 7+ years of relevant experience
• PE license preferred, or ability to obtain
• Experience with A&E consulting or pharmaceutical manufacturing preferred
• Can lead and mentor junior engineers in a specific area of focus within life science industry or engineering design deliverables
• Experience executing projects requiring process design, fluid mechanics, heat transfer, and/or mass balance principles.
• Experience reviewing and redlining process drawings
• Experience with process engineering software, including:
  • Drawing tools (AutoCAD, Revit, Plant3D)
  • Fluid flow, equipment sizing and design (AFT Fathom, Arrow)
  • Capacity modeling and simulation (Flex Sim, Schedule Pro)
  • HAZOP reviews and assessments (PHA Pro)
• Experience leading HAZOP reviews and risk assessment methodology
• Experienced with process equipment for specific modalities, such as biologics (bioreactors, TFF, chromatography) and clean utilities (purified water, pure steam, compressed gases, aseptic fill/finish, or other relevant systems).
• Experience executing process engineering projects for various applications and project sizes
• Understanding of different regulatory requirements and ability to appropriately apply expectations to different submarkets.
• Demonstrates advanced critical thinking and problem-solving skills, with the…