Contract CQV Engineer: Biopharma Commissioning & Validation

Intellectt INC; North Carolina; On-site; USD 114,616,000 - 157,597,000; Full time

Job summary

Intellectt INC in Holly Springs, NC is seeking a CQV Engineer to support final Commissioning, Qualification, and Validation activities for a biopharmaceutical manufacturing expansion.

You will focus on operational C&Q of upstream/downstream process equipment, automation, and associated utilities, collaborating with Engineering, Quality, and vendor teams.

This contract role requires a Bachelor's degree and 3+ years of CQV in GMP environments, with hands-on field verification and system walkdowns.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of CQV/C&Q/validation experience in pharma/biopharma manufacturing.
• Hands-on field verification, system walkdowns and equipment qualification.
• Experience interpreting P&IDs, drawings, and equipment documentation in GMP settings.

Responsibilities

• Perform field verification of P&IDs, datasheets, vendor drawings, isometrics, and system boundaries.
• Conduct system completion walkdowns and review turnover packages, punch lists, calibrations, weld docs, redlines.
• Execute commissioning and qualification for upstream equipment (bioreactors, incubators, pumps, centrifuges).
• Execute C&Q for downstream equipment (chromatography skids, UF/DF, viral filtration).
• Identify and resolve startup issues and documentation discrepancies.
• Collaborate with Engineering, Construction, Automation, Quality, Operations, and vendors.

Skills

CQV experience

GMP environment

P&IDs interpretation

Cross-functional

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Intellectt INC in Holly Springs, NC is seeking a CQV Engineer to support final Commissioning, Qualification, and Validation activities for a biopharmaceutical manufacturing expansion.

You will focus on operational C&Q of upstream/downstream process equipment, automation, and associated utilities, collaborating with Engineering, Quality, and vendor teams.

This contract role requires a Bachelor's degree and 3+ years of CQV in GMP environments, with hands-on field verification and system walkdowns.