Senior CQV Engineer — Plasma Biopharma GMP Onsite

i-Pharm GxP

Illinois

In loco

USD 90.000 - 130.000

Tempo pieno

33 ore fa

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Descrizione del lavoro

i-Pharm GxP is seeking a Senior CQV Engineer for a hands-on role in plasma fractionation and purification systems in Kankakee, Illinois. You will drive commissioning, qualification, and validation from construction through handover on-site five days a week.

The ideal candidate has 5+ years of C&Q in GMP facilities, with plasma-derived product experience and Kneat protocol development, plus knowledge of cGMP and calibration of validation processes. Overtime may be required.

Competenze

5+ years hands-on C&Q experience in GMP facilities.
Direct plasma-derived products or downstream biologics experience.
Protocol development and execution experience, ideally in Kneat or a similar electronic validation system.
Good understanding of cGMP, ASTM E2500 and risk-based C&Q.
Experience with temperature mapping or cold chain qualification is a strong plus.
Greenfield or facility expansion experience; exposure to DeltaV/SCADA desirable.

Mansioni

Commissioning and qualifying plasma processing equipment, including thaw, pooling, fractionation and more.
Support associated systems: CIP/SIP, WFI and purified water, cold rooms, freezers, and temperature-controlled storage.
Carry out P&ID walkdowns, loop checks, component verification and functional testing in the field.
Develop and execute IQ/OQ/PQ protocols, ideally in Kneat, and supporting FAT/SAT.
Work through punch lists, deviations and troubleshooting to keep systems moving.
Build turnover packages and traceability matrices for handover.
Collaborate with Construction, Engineering, Automation, Validation and QA to meet GMP standards.