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Senior Validation Engineer Jobs in Chicago, IL (NOW HIRING)

Senior Engineer, Process Validation

Chicago, IL ยท On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Senior Engineer, Process Validation

Chicago, IL ยท On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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Senior Validation Engineer information

See Chicago, IL salary details

$35

$66

$101

How much do senior validation engineer jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for senior validation engineer in Chicago, IL is $66.72, according to ZipRecruiter salary data. Most workers in this role earn between $53.22 and $75.77 per hour, depending on experience, location, and employer.

What does a senior validation engineer do?

A Senior Validation Engineer is responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They develop and execute validation protocols, analyze test data, and document results to confirm compliance with industry and company standards. Senior Validation Engineers often lead validation projects, collaborate with cross-functional teams, and mentor junior staff. Their work is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where product safety and efficacy are essential.

What are the key skills and qualifications needed to thrive as a senior validation engineer, and why are they important?

To thrive as a Senior Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically supported by a relevant degree and experience in validation within regulated industries. Familiarity with validation protocols (IQ, OQ, PQ), statistical analysis tools, and systems like FDA 21 CFR Part 11 is crucial. Strong problem-solving, attention to detail, and effective communication skills help ensure successful project outcomes and cross-functional collaboration. These skills and qualifications are essential to maintain product quality, meet regulatory standards, and drive continuous improvement.

What are some typical challenges faced by senior validation engineers when leading validation projects?

Senior Validation Engineers often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating cross-functional teams. Balancing the needs of production, quality assurance, and regulatory affairs requires strong communication and project management skills. Additionally, troubleshooting unexpected validation failures and documenting results thoroughly are key aspects that demand both technical expertise and attention to detail.

What is the difference between Senior Validation Engineer vs Validation Specialist?

AspectSenior Validation EngineerValidation Specialist
CredentialsBachelor's or Master's in Engineering, Life Sciences, or related fields; often with certifications like GxP or CSVSimilar educational background; certifications like GxP or CSV are common
Work EnvironmentDesigns and oversees validation protocols in manufacturing, biotech, or pharmaceutical settingsExecutes validation tasks, tests, and documentation in similar environments
Employer & IndustryPharmaceutical, biotech, medical device companiesSame industries, often working under validation teams
Search & ComparisonOften compared for experience level and responsibilitiesCommonly searched together for validation roles

The main difference is that a Senior Validation Engineer typically leads validation projects, designs protocols, and oversees validation activities, while a Validation Specialist focuses on executing validation tests and documentation. Both roles require similar credentials and work in comparable environments, but the Senior Validation Engineer has more responsibility for planning and oversight.

What are the most commonly searched types of Validation Engineer jobs in Chicago, IL?

The most popular types of Validation Engineer jobs in Chicago, IL are:

What job categories do people searching Senior Validation Engineer jobs in Chicago, IL look for?

The top searched job categories for Senior Validation Engineer jobs in Chicago, IL are:

What cities near Chicago, IL are hiring for Senior Validation Engineer jobs?

Cities near Chicago, IL with the most Senior Validation Engineer job openings:

Infographic showing various Senior Validation Engineer job openings in Chicago, IL as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 100% In-person job distribution, with an average salary of $138,788 per year, or $66.7 per hour.

Sr. Validation Engineer

Sterling Engineering Inc.

Waukegan, IL โ€ข On-site

$60 - $75/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 2 days ago

New


Job description

Position: Sr Validation Engineer
Location: Waukegan, IL 60087 onsite 5 days a week
Duration: 12+ months

Pay Rate $60.00 -$75.00 per hour W2 + 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.
  • Strong process-equipment qualification experience.
  • 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.
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.