Commissioning, Qualification, and Validation (CQV) Engineer

Eurofins USA BioPharma Services•Raleigh, PA

17h

About The Position

This is a hands-on commissioning, qualification, and validation role with high growth potential. The CQV Engineer works alongside the CQV Lead on facility, utility, and equipment qualification programs for pharmaceutical and biotechnology clients. The work includes writing and executing protocols, performing field activities, and developing toward independent ownership of systems. The position is suited to someone with GMP experience who wants to move further into validation. As experience grows, the engineer may take ownership of systems end to end, mentor newer engineers, and lead qualification workstreams.

Requirements

At least two years of hands-on experience in a GMP-regulated environment, with direct involvement in commissioning, qualification, or validation activity.
Working understanding of IQ, OQ, and PQ and why qualification documentation matters.
Ability to read and work from technical drawings, particularly P&IDs.
Clear technical writing skills; the role produces documents that may be read by a regulator.
Familiarity with cGMP under 21 CFR Parts 210 and 211 and good documentation practice.
Careful, accurate, methodical work habits and comfort maintaining a document trail.
Valid driver's licence.
Ability to work on active construction and manufacturing sites, including gowned work and occasional extended hours during qualification campaigns.

Nice To Haves

Degree in engineering, microbiology, or a life science; equivalent hands-on experience will be considered instead.
Utilities experience, including water for injection, purified water, clean steam, compressed air, nitrogen, or oxygen.
Environmental monitoring, aseptic operations, or cleanroom experience.
Experience with MODA, LIMS, or other electronic data systems, and computer system validation under GAMP 5.
Risk assessment methodology under ICH Q9 or FMEA facilitation.
Knowledge of EU GMP Annex 1, ISO 14644, or USP compendial testing requirements.
Experience with electronic validation platforms such as Kneat.

Responsibilities

Author and execute IQ, OQ, and PQ commissioning and qualification protocols for utilities, equipment, and facilities.
Perform field verification and walkdowns against P&IDs, and log discrepancies for resolution.
Execute qualification sampling programs and maintain complete, accurate sample logs, chain-of-custody records, and executed protocols.
Write deviation reports and summary reports, and support investigations.
Support risk assessments and FMEAs, including the sampling plans that follow from them.
Support change control and help close out qualification packages.
Work on site with client engineering and quality teams, representing Eurofins professionally.
As experience grows, take ownership of systems end to end, mentor newer engineers, and lead qualification workstreams.