Validation Engineer

Validation Engineer (CQV)

Location:

Raleigh-Durham area, NC

We are seeking an experienced Validation Engineer (CQV) to support commissioning, qualification, and startup activities for a large‑scale biopharmaceutical manufacturing facility. This role will focus on downstream process systems and requires strong hands‑on field execution, system troubleshooting, and automation verification experience in a GMP‑regulated environment.

• Perform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, and utility connections to confirm system accuracy and readiness ahead of commissioning and startup.
• Lead and execute mechanical completion walkdowns and turnover package (TOP) reviews, ensuring construction quality, punch list closure, calibration records, weld documentation, and redline updates are complete.
• Support commissioning readiness by validating system boundaries, flow paths, and equipment installation in alignment with design documentation.
• Execute commissioning and qualification (CQV) activities for downstream process equipment, including:
  • Chromatography skids
  • Ultrafiltration/Diafiltration (UF/DF) systems
  • Viral filtration systems
  • Depth filtration units
  • Buffer preparation vessels
  • Product hold tanks
• Perform field startup and functional testing of chromatography systems, including:
  • Flow path verification
  • Valve sequencing checks
  • Conductivity and pressure monitoring
  • Automation functionality validation
• Conduct Operational Qualification (OQ) testing for automated systems using DeltaV, including:
  • Loop checks and I/O verification
  • Interlock and permissive testing
  • Alarm challenge testing
  • Control logic and sequence verification under live conditions
• Verify process alarms, interlocks, per missives, and emergency shutdown functions through field execution and control system testing.
• Perform detailed P& and field verification of valves, instruments, and process flow to support system turnover, TOP approval, and final acceptance.
• Identify and troubleshoot startup issues related to:
  • Automation logic and control sequences
  • Valve sequencing and flow path discrepancies
  • Equipment integration and skid interfaces
  • Cleaning cycle performance
• Collaborate cross‑functionally with engineering, construction, and operations teams to maintain project timelines and ensure successful system startup.

• Bachelor's degree in Engineering (Chemical, Mechanical, or related discipline) or equivalent industry experience.
• 5+ years of experience in CQV, commissioning, or validation within biopharmaceutical or life‑sciences manufacturing.
• Hands‑on experience with downstream processing equipment, especially chromatography and filtration systems.
• Strong knowledge of cGMP requirements, commissioning processes, and validation lifecycle.
• Experience executing OQ protocols and field testing activities.
• Familiarity with DeltaV or similar DCS platforms (Emerson experience preferred).
• Proficiency in reading and interpreting P&IDs, isometrics, and technical drawings.
• Demonstrated ability to work in a fast‑paced startup environment with significant field presence.

• Previous experience supporting greenfield or large‑scale capital projects.
• Strong troubleshooting and problem‑solving skills in live plant environments.
• Experience with automation systems integration and process control verification.
• Ability to manage multiple systems and priorities during commissioning/startup phases.

• Primarily field‑based role with significant time in manufacturing and construction areas.
• Requires coordination with multiple stakeholders across CQV, engineering, and operations.
• May involve extended hours during critical commissioning and startup windows.

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well‑being, and future.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug‑Free Workplace.