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Sterling-engineering • Illinois, United States
Role & seniority: Senior Validation Engineer / Senior Validation Lead (10+ years’ experience)
Stack/tools: API manufacturing validation; IQ/OQ/PQ/C&Q; Validation Master Plans (VMPs); change control; deviation investigations; CAPA; electronic validation/document management systems; risk-based validation; cGMP and 21 CFR guidelines
Lead validation activities across API manufacturing systems, equipment, utilities, and facilities
Maintain/update VMPs and site validation procedures; oversee IQ/OQ/PQ/C&Q activities
Support change control, deviations, CAPA, validation impact assessments; author/review/route validation documentation; provide cross-functional guidance
Must-have skills: 10+ years in validated/pharma manufacturing environments; direct API manufacturing experience; equipment/facility/utility qualification; change management in validated systems; working knowledge of cGMP, 21 CFR, risk-based validation; experience with electronic validation systems; ability to work 100% onsite; local travel; US work authorization without sponsorship
Nice-to-haves: Site lead for electronic validation platforms; template management; training support; experience with documentation in electronic systems
Location & work type: Lake County, IL; onsite; 12-36 month contract; W2; full benefits; long-term onsite opportunity; no visa sponsorship (not open to C2C)
Position: Sr Validation Engineer
Location: Lake County, IL
Duration: 12-36 months
This opportunity is to join the Sterling Team! The Sterling Engineering Team is seeking a Senior Validation Lead with 10+ years experience to support a complex, multi-building pharmaceutical manufacturing site with significant equipment operations.
This is a long-term onsite contract role supporting equipment, utilities, facilities, and change management activities within a highly regulated cGMP production environment.
This position requires a seasoned validation professional who can operate independently, provide technical leadership, and support high-visibility manufacturing operations.
Key Responsibilities Lead validation activities across API manufacturing systems, equipment, utilities, and facilities Maintain and update Validation Master Plans (VMPs) and site validation procedures Support change control, deviation investigations, CAPA activities, and validation impact assessments Oversee and approve IQ, OQ, PQ, and C&Q activities Author, review, route, and approve validation documentation within electronic systems Provide validation strategy and technical guidance across cross-functional teams Serve as site lead for electronic validation execution platforms (issue resolution, template management, training support)
Required Qualifications Minimum 10+ years of validation experience within U.S.-based regulated pharmaceutical manufacturing environments Direct experience supporting API manufacturing operations Strong background in equipment, facility, and utility qualification Demonstrated experience with change management in validated systems Working knowledge of cGMP, 21 CFR, and risk-based validation methodologies Experience with electronic validation/document management systems Ability to work 100% onsite and ability to travel locally Long-term contract opportunity with full benefits W2 only Not open to C2C No visa sponsorship available now or in the future Must be authorized to work in the United States without sponsorship
About us…Sterling Engineering, in business for 56 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.