CQV Engineer: GMP-Driven Commissioning & Qualification

Eurofins BioPharma Product Testing North America; Boston (MA); Vor Ort; USD 90.000 - 140.000; Vollzeit

Benefits dieser Stelle

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Medical, dental and vision coverage

Zusammenfassung

Eurofins USA BioPharma Services seeks a hands-on CQV professional for commissioning, qualification and validation in pharmaceutical/biotechnology settings in the Boston area. You will write and execute IQ/OQ/PQ for utilities, equipment and facilities, and collaborate with engineering and QA teams to deliver compliant qualification programs.

Applicants should have 2+ years in a GMP-regulated environment, read P&IDs, and demonstrate strong technical writing.

Qualifikationen

• Two+ years in GMP-regulated environment with commissioning/qualification/validation exposure.
• Understanding of IQ, OQ, PQ and qualification docs importance.
• Ability to read technical drawings, especially P&IDs.
• Clear technical writing for regulator-read documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211; good documentation practice.
• Engineering or life science degree preferred; equivalent hands-on experience considered.
• Willingness to work on active construction/manufacturing sites; valid driver’s license.

Aufgaben

• Author and execute commissioning and qualification protocols (IQ/OQ/PQ) for utilities, equipment and facilities.
• Perform field verifications and log discrepancies against P&IDs.
• Execute sampling programs; maintain logs, chain of custody and protocols.
• Write deviation and summary reports and support investigations.
• Support risk assessments and FMEAs and the corresponding sampling plans.
• Assist change control and close out qualification packages.
• Collaborate with client engineering and quality teams on site; represent Eurofins professionally.
• As growth occurs, own systems end-to-end, mentor juniors, and lead qualification workstreams.

Kenntnisse

GMP environment experience

IQ/OQ/PQ understanding

Reading P&IDs

Technical writing

cGMP knowledge (21 CFR 210/211)

Document trail discipline

Valid driver’s license

Ausbildung

Engineering, Microbiology or Life Science degree

Jobbeschreibung

Eurofins USA BioPharma Services seeks a hands-on CQV professional for commissioning, qualification and validation in pharmaceutical/biotechnology settings in the Boston area. You will write and execute IQ/OQ/PQ for utilities, equipment and facilities, and collaborate with engineering and QA teams to deliver compliant qualification programs.

Applicants should have 2+ years in a GMP-regulated environment, read P&IDs, and demonstrate strong technical writing.