CQV Engineer: GMP Validation & Qualification Pro

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) match

Paid vacation

Paid holidays

Job summary

Eurofins USA BioPharma Services is seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our Boston area team. You will author and execute IQ/OQ/PQ protocols for utilities, equipment, and facilities, and perform field verifications against P&IDs.

You will collaborate with client engineers and quality groups, grow into owning end-to-end qualification workstreams, and travel as needed to support campaigns on site in GMP environments.

Qualifications

• Two+ years hands-on GMP-regulated experience in commissioning, qualification or validation.
• Understanding of IQ, OQ, PQ and qualification documentation.
• Ability to read technical drawings and P&IDs.
• Strong technical writing for regulator-read documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211.
• Degree in engineering or life sciences preferred; equivalent hands-on experience accepted.
• Willingness to work on active construction sites and travel.

Responsibilities

• Author and execute IQ/OQ/PQ protocols for facilities, utilities and equipment.
• Perform field verifications against P&IDs and log discrepancies.
• Maintain sample logs and documentation for validation campaigns.
• Write deviation reports and summary reports; support investigations.
• Support risk assessments and FMEAs, and related sampling plans.
• Assist change control and close out qualification packages.
• Collaborate with client engineering and quality teams on site.
• Grow into owning end-to-end qualification workstreams.

Skills

GMP experience

IQ/OQ/PQ

Reading P&IDs

Technical writing

Field verification

Education

Engineering degree

Job description

Eurofins USA BioPharma Services is seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our Boston area team. You will author and execute IQ/OQ/PQ protocols for utilities, equipment, and facilities, and perform field verifications against P&IDs.

You will collaborate with client engineers and quality groups, grow into owning end-to-end qualification workstreams, and travel as needed to support campaigns on site in GMP environments.