CQV Engineer: Own End-to-End Qualification

Eurofins; Boston (MA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Medical, dental and vision coverage

Job summary

Eurofins USA BioPharma Services in Boston, MA is seeking a hands-on CQV Engineer to lead commissioning, qualification and validation programs for pharmaceutical facilities.

You will author and execute IQ, OQ and PQ protocols, perform field verifications against P&IDs, log discrepancies and support investigations.

Grow to own systems end-to-end, mentor junior engineers, and collaborate with client engineering and quality teams on site. Excellent full-time benefits are provided.

Qualifications

• Two or more years of GMP-regulated experience with commissioning, qualification or validation.
• Understanding of IQ, OQ and PQ and why qualification documentation matters.
• Ability to read technical drawings, particularly P&IDs.
• Clear technical writing for regulator-ready documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211 and with good documentation practice.
• Degree in engineering, microbiology or life science preferred; equivalent hands-on experience considered.

Responsibilities

• Author and execute IQ, OQ and PQ protocols for utilities, equipment and facilities.
• Perform field verifications and walkdowns against P&IDs; log discrepancies.
• Execute qualification sampling programs and maintain records.
• Write deviation reports and summary reports; support investigations.
• Support risk assessments and FMEAs; follow-on sampling plans.
• Support change control and close out qualification packages.
• Work with client engineering and quality teams on site; represent Eurofins professionally.
• Grow to own systems end-to-end and mentor newer engineers.

Skills

GMP experience

IQ/OQ/PQ knowledge

P&ID reading

Technical writing

Field verification

Risk assessments & FMEA

Change control

On-site collaboration

Mentoring

Education

Engineering degree

Biology/Microbiology/Life science degree

Tools

Kneat

LIMS

Job description

Eurofins USA BioPharma Services in Boston, MA is seeking a hands-on CQV Engineer to lead commissioning, qualification and validation programs for pharmaceutical facilities.

You will author and execute IQ, OQ and PQ protocols, perform field verifications against P&IDs, log discrepancies and support investigations.

Grow to own systems end-to-end, mentor junior engineers, and collaborate with client engineering and quality teams on site. Excellent full-time benefits are provided.