Commissioning, Qualification, and Validation (CQV) Engineer

This is a hands-on commissioning qualification and validation role with high growth potential. You will work alongside our CQV Lead on facility utility and equipment qualification programs for pharmaceutical and biotechnology clients writing and executing protocols working in the field and building toward owning systems independently. 

We are looking for someone with real GMP experience who wants to move further into validation than their current role allows. 

• Author and execute commissioning and qualification protocols IQ OQ and PQ 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 records sample logs chain of custody and executed protocols. 

• Write deviation reports and summary reports and support investigations. 

• Support risk assessments and FMEAs and the sampling plans that follow from them. 

• Support change control and help close out qualification packages. 

• Work with client engineering and quality teams on site representing Eurofins professionally. 

• As you grow: take ownership of systems end to end mentor newer engineers and lead your own qualification workstreams. 

Qualifications :

Must haves: 

• Two or more years of hands-on experience in a GMP-regulated environment with direct involvement in commissioning qualification or validation activity. We will consider strong candidates from adjacent roles QC or laboratory analysts who have executed equipment qualifications calibration and metrology technicians manufacturing or maintenance engineers from a pharmaceutical site. 

• A working understanding of IQ OQ and PQ and of why qualification documentation matters. 

• Ability to read and work from technical drawings particularly P&IDs. 

• Clear technical writing. Much of this role is producing documents that a regulator may read. 

• Familiarity with cGMP under 21 CFR Parts 210 and 211 and with good documentation practice. 

• Degree in engineering microbiology or a life science is preferred. Equivalent hands-on experience will be considered in its place. 

• Careful accurate and methodical. Comfortable being held to a document trail. 

• Valid drivers licence. Able to work on active construction and manufacturing sites including gowned work and occasional extended hours during qualification campaigns. 

None of the following are expected on day one. Each is something we will teach and each is a reason to put your application forward. 

• Utilities experience water for injection purified water clean steam compressed air nitrogen oxygen. 

• Environmental monitoring aseptic operations or cleanroom experience. 

• MODA LIMS or other electronic data systems and computer system validation under GAMP 5. 

• Risk assessment methodology under ICH Q9 or FMEA facilitation. 

• EU GMP Annex 1 ISO 14644 or USP compendial testing requirements. 

• Electronic validation platforms such as Kneat. 

Additional Information :

Positions are full-time working Monday-Friday 8am-5pm overtime as needed. Candidates currently  living within commutable distance to Raleigh NC  are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage dental and vision options

• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time