Job Description

Technical Source’s pharmaceutical manufacturing client is expanding its drug substance (DS) manufacturing capabilities at a North Carolina site. We are seeking a Senior Process / Equipment Engineer to join the Drug Substance Process Systems / Utilities Engineering team and own critical upstream and downstream process systems from design through startup.

The project is currently in the equipment design phase This engineer will step in now to support design reviews and then carry their equipment scope through mechanical completion, commissioning, qualification, and startup for a large-scale biologics facility featuring five 10,000 L bioreactors and one purification train

This is a hands-on, capital project–focused role, 100% onsite in North Carolina, for a 2-year assignment.

Key Responsibilities

• Serve as the process equipment engineering lead for a defined subset of upstream and/or downstream systems, which may include:
  • Large stainless-steel bioreactors (up to 10,000 L)
  • Tangential flow filtration (TFF) skids
  • Chromatography skids
  • Viral filtration and depth filtration systems
  • Large stainless steel tank skids (media, buffer, hold tanks)
• Support and lead equipment design reviews
  • Review and comment on vendor P&IDs, GA drawings, and specifications.
  • Ensure designs meet ASME BPE, hygienic piping, weld, and fabrication standards.
  • Translate process requirements, mass balances, and process flows into clear equipment and automation (DeltaV) requirements.
• Partner with Automation (DeltaV) to:
  • Define control strategies, interlocks, and alarm philosophies.
  • Ensure process needs are correctly implemented in DeltaV control modules, phases, and recipes.
• Drive equipment through mechanical completion (MC) to startup:
  • Support field installation, walkdowns, and punchlist closure.
  • Coordinate equipment integration with process and utility systems.
• Support commissioning and qualification (C&Q) activities:
  • Contribute to or review URS, FRS, DS, and IQ/OQ documentation.
  • Support execution of commissioning and qualification protocols.
  • Troubleshoot and resolve technical issues during C&Q and startup.
• Participate in and support facility shutdowns, tie-ins, and startup planning for assigned systems.
• Work closely with cross-functional partners:
  • Process Systems / Utilities Engineering, Automation, CQV, Manufacturing, and Quality to deliver fully qualified, operable equipment on schedule.

Basic Qualifications

One of the following combinations of education and experience:

• Master’s degree & 6–8 years of engineering experience; OR
• Bachelor’s degree & 8+ years of engineering experience; OR
• Associate’s degree & 10+ years of engineering experience

Required Experience & Skills

• Proven experience leading design and supporting installation of one or more of the following systems in a GMP biopharmaceutical or biologics environment:
  • Tangential flow filtration (TFF)
  • Chromatography skids
  • Viral filtration and/or depth filtration systems
  • Large stainless steel tank skids
  • (Strong plus) Large stainless-steel bioreactors (≥ 5,000 L, ideally 10,000 L)
• Direct involvement in commissioning and qualification (C&Q) of process equipment:
  • Experience supporting MC, commissioning, and IQ/OQ (PQ a plus).
  • Familiarity with risk-based qualification approaches and CQV practices.
• Working knowledge of ASME BPE and:
  • Hygienic/sanitary piping design
  • Fabrication and weld inspection
  • Testing criteria (e.g., pressure tests, boroscope inspections where applicable)
• Strong process automation background
  • Ability to translate process information (PFDs, P&IDs, mass balances, URS) into automation requirements.
  • Experience collaborating closely with DeltaV teams (not necessarily programming, but strong understanding of control strategies and batch operations).
• Solid understanding of drug substance (DS) processes
  • Upstream and/or downstream process flows and unit operations.
  • Process requirements, mass balances, and interactions between unit operations.
• Demonstrated experience working during facility shutdowns and tie-ins
  • Planning and execution support for critical connections, cutovers, and startup activities in an operating or soon-to-be-operational facility.

Preferred Qualifications

• Experience with large molecule biologics (e.g., mAbs, recombinant proteins) in commercial or late-stage clinical manufacturing.
• Prior work on capital expansion or greenfield projects in a GMP biologics facility.
• Experience with:
  • Vendor management (design reviews, FAT/SAT participation, issue resolution).
  • Risk-based CQV approaches (ASTM E2500 or similar).
• Strong documentation skills and familiarity with GMP change control, deviations, and technical reports.
• Ability to lead cross-functional technical discussions and drive decisions in a fast-paced project environment.