Commissioning, Qualification, and Validation (CQV) Engineer

Eurofins USA BioPharma Services•Lancaster, PA

6h•Onsite

About The Position

This is a hands-on commissioning, qualification, and validation role supporting pharmaceutical and biotechnology clients. The CQV Engineer works alongside the CQV Lead on facility, utility, and equipment qualification programs, authoring and executing protocols, performing fieldwork, and developing toward independent system ownership. The position is suited to someone with GMP experience who wants to build further expertise in validation. As experience grows, the engineer may take ownership of systems end to end, mentor newer engineers, and lead qualification workstreams. The role involves working on client sites and may include gowned work and occasional extended hours during qualification campaigns.

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 the importance of qualification documentation.
Ability to read and work from technical drawings, particularly P&IDs.
Clear technical writing skills.
Familiarity with cGMP under 21 CFR Parts 210 and 211 and with good documentation practice.
Careful, accurate, and methodical approach, with 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

A degree in engineering, microbiology, or a life science is preferred; equivalent hands-on experience may be considered instead.
Experience in utilities such as 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.
Knowledge of 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 accurate records, including sample logs, chain of custody, and executed protocols.
Write deviation reports and summary reports, and support investigations.
Support risk assessments and FMEAs, as well as resulting sampling plans.
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.