CQV Engineer

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

Job Title: CQV Engineer

Location: Holly Springs, NC
Employment Type: Contract
Duration: 6 Months+

Job Summary

We are seeking a CQV Engineer to support final Commissioning, Qualification, and Validation activities for a biopharmaceutical manufacturing expansion. The role will focus on operational C&Q of upstream/downstream process equipment, automation, and associated utilities.

Responsibilities

• Perform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, utility connections, and system boundaries.


• Conduct system completion walkdowns and review turnover packages, punch lists, calibration records, weld documentation, and redlines.


• Execute commissioning and qualification activities for upstream equipment including bioreactors, media prep systems, incubators, pumps, and centrifuges.


• Execute C&Q activities for downstream equipment including chromatography skids, UF/DF systems, and viral filtration.


• Identify and support resolution of startup issues and documentation discrepancies.


• Collaborate with Engineering, Construction, Automation, Quality, Operations, and vendors to support system readiness and turnover.

Required Qualifications

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


• 3+ years of CQV, C&Q, Commissioning, or Validation experience in pharmaceutical/biopharmaceutical manufacturing.


• Hands-on experience with field verification, system walkdowns, equipment qualification, and commissioning.


• Strong experience interpreting P&IDs, drawings, equipment documentation, and system boundaries.


• Experience with GMP-regulated manufacturing environments and CQV documentation.

Salary

The hourly rate for this position is $40-55 per hour.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.