Senior Validation Engineer

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

Location: Waukegan, IL 60087 onsite 5 days a week

Duration: 12+ months

Pay Rate $60.00 -$75.00 per hour W2 + Full Benefits

I am looking for a CQV Project Lead to independently manage equipment qualification projects within an API Pilot Plant and clinical drug-substance manufacturing environment. This role primarily supports process and equipment CQV—not facilities validation.

The ideal candidate has 10+ years of pharmaceutical commissioning, qualification, or validation experience and can independently develop, execute, and close complete qualification packages.

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.

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.

About us…Sterling Engineering, in business for 57 years …

we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.

• Paid Time Off
• Paid Holidays
• 3 Medical plans to choose from
• Dental & Vision plans
• 401(k) with a match
• Employee Stock Ownership (ESOP) plan

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.