CQV Engineer: GMP Validation, Commissioning, & Utilities

Eurofins; Edison (NJ); Vor Ort; USD 85.000 - 105.000; Vollzeit

Benefits dieser Stelle

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Zusammenfassung

Eurofins Scientific is seeking a hands-on CQV Engineer to join our team in Edison, NJ. You will work with the CQV Lead on facility, utility and equipment qualification programs, authoring IQ/OQ/PQ protocols, performing field walkdowns, and maintaining rigorous documentation for GMP-compliant projects.

Ideal candidates have 2+ years in GMP-regulated environments, reading P&ID drawings, strong technical writing, and a willingness to grow into leading qualification workstreams.

Qualifikationen

• Two or more years of hands-on GMP-regulated experience with commissioning, qualification or validation.
• Ability to read and work from technical drawings, particularly P&IDs.
• Strong technical writing for regulator-facing documents.

Aufgaben

• Author and execute IQ, OQ and PQ for utilities, equipment and facilities.
• Perform field verification and walkdowns against P&IDs, logging discrepancies.
• Execute qualification sampling programs and maintain complete records (logs, chain of custody).
• Write deviation and summary reports and support investigations.
• Support risk assessments and FMEAs and the resulting sampling plans.

Kenntnisse

GMP experience

IQ/OQ/PQ understanding

Technical writing

P&IDs reading

Field experience

Ausbildung

Engineering degree

Life science degree preferred

Tools

Kneat

Jobbeschreibung

Eurofins Scientific is seeking a hands-on CQV Engineer to join our team in Edison, NJ. You will work with the CQV Lead on facility, utility and equipment qualification programs, authoring IQ/OQ/PQ protocols, performing field walkdowns, and maintaining rigorous documentation for GMP-compliant projects.

Ideal candidates have 2+ years in GMP-regulated environments, reading P&ID drawings, strong technical writing, and a willingness to grow into leading qualification workstreams.