Senior CQV Project Lead - Pharma Validation (Onsite IL)

Sterling Engineering; Waukegan (IL); On-site; USD 83,000 - 103,000; Full time

Benefits offered by this job

Full benefits

Paid time off

Paid holidays

Medical plans (3)

Dental & Vision plans

401(k) match

ESOP

Job summary

Sterling Engineering in Waukegan, IL is seeking a CQV Project Lead to independently manage equipment qualification projects within an API pilot plant and clinical drug-substance manufacturing environment. This role focuses on CQV for process and equipment, not facilities validation.

The ideal candidate has 10+ years of pharmaceutical commissioning, qualification, or validation experience and can develop, execute, and close complete qualification packages, reviewing P&IDs and documentation with

Qualifications

• 10+ years of pharmaceutical CQV or validation experience.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols.
• Ability to independently own qualification packages and manage CQV projects.
• Experience reviewing P&IDs and technical equipment documentation.
• Experience managing deviations, discrepancies, and punch-list items.
• Strong GMP documentation and change-control experience.
• API, small-molecule, drug-substance, pilot-plant, or specialty chemical manufacturing experience.
• Experience qualifying reactors, mix tanks, process piping, instrumentation, portable equipment, or potent-compound isolators.
• ADC or biotechnology manufacturing experience.
• Experience with single-use systems, single-use mixers, UF/DF systems, Cytiva equipment, or antibody-processing equipment.
• Kneat or Kneat Gx experience.
• DeltaV or PLC validation experience.
• Experience performing I/O checks and verifying controls, HMI screens, alarms, interlocks, and operating sequences.
• Nitrogen or process-piping utility qualification experience.

Responsibilities

• Independently own CQV projects and qualification packages from planning through final closeout.
• Develop and execute commissioning, IQ, OQ, and PQ protocols.
• Qualify pharmaceutical process and portable equipment.
• Support reactors, mix tanks, process piping, instrumentation, and potent-compound isolators.
• Review P&IDs, equipment drawings, specifications, and turnover documentation.
• Conduct equipment walkdowns and installation verification.
• Document discrepancies and manage deviations, punch lists, and protocol exceptions through closure.
• Support nitrogen and process-piping utility qualification.
• Coordinate with Engineering, Manufacturing, Quality, Automation, vendors, and other project stakeholders.
• Maintain accurate, traceable, and inspection-ready GMP documentation.
• Author and execute qualification documentation using Kneat when applicable.

Skills

CQV

IQ/OQ/PQ

Qualification packages

P&IDs review

Deviations management

GMP documentation

Change control

API/drug-substance

Kneat

Kneat Gx

DeltaV/PLC validation

I/O checks & controls

Nitrogen utility qualification

Tools

Kneat

Kneat Gx

DeltaV

PLC validation

Job description

Sterling Engineering in Waukegan, IL is seeking a CQV Project Lead to independently manage equipment qualification projects within an API pilot plant and clinical drug-substance manufacturing environment. This role focuses on CQV for process and equipment, not facilities validation.

The ideal candidate has 10+ years of pharmaceutical commissioning, qualification, or validation experience and can develop, execute, and close complete qualification packages, reviewing P&IDs and documentation with