Senior CQV Engineer

i-Pharm GxP; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

C&Q experience

Plasma-derived products

Kneat protocol development

cGMP & ASTM E2500 knowledge

Temperature mapping

DeltaV/SCADA familiarity

Bachelor's degree required

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

DeltaV

SCADA

Job description

Senior CQV Engineer, Plasma-Derived Therapies | Kankakee, Illinois

We’re looking for an experienced Senior CQV Engineer to join a major biopharmaceutical capital program in Kankakee, Illinois. You’ll sit within the process team, delivering commissioning, qualification and validation of plasma fractionation and purification systems from construction through to handover.

This is a hands‑on, field‑based role for someone who understands plasma processes, is comfortable working alongside construction and engineering, and can contribute from day one.

• Initial 12-month contract, with extensions anticipated


• Fully onsite in Kankakee, Illinois, five days a week

What you’ll be doing:

• Commissioning and qualifying plasma processing equipment, including plasma thaw and pooling, fractionation and precipitation, centrifugation, chromatography, ultrafiltration/diafiltration, viral inactivation and nanofiltration systems.


• Supporting associated systems, including CIP/SIP, WFI and purified water, cold rooms, freezers and temperature-controlled storage.


• Carrying out P&ID walkdowns, loop checks, component verification and functional testing in the field.


• Developing and executing IQ/OQ/PQ protocols, ideally in Kneat, and supporting FAT/SAT.


• Working through punch lists, deviations and troubleshooting to keep systems moving.


• Building turnover packages and traceability matrices for handover.


• Working with Construction, Engineering, Automation, Validation and QA to deliver systems to GMP standards.

What we’re looking for:

• 5+ years of hands‑on C&Q experience in pharmaceutical or biotech GMP facilities.


• Direct experience with plasma-derived products or downstream biologics processing.


• Protocol development and execution experience, ideally in Kneat or a similar electronic validation system.


• A 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 is a strong plus. Exposure to DeltaV, SCADA or building automation is desirable.


• A Bachelor’s degree in Engineering, Life Sciences or a related technical field.


• Availability for overtime and occasional weekend work when the schedule requires it.