- 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)
- 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
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Sr Validation Engineer - Round Lake - Sterling Engineering
Description
Position: Sr Validation Engineer
Location: Lake County, IL
Duration: 12-36 months
Before applying for this role, please read the following information about this opportunity found below.
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
Required Qualifications
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. xhmxlyz
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.
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Validation Engineer
Only for registered members Round Lake
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Validation Engineer
Only for registered members Round Lake
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Equipment Validation Engineer
Only for registered members Round Lake
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Equipment Validation Engineer
Only for registered members Round Lake, IL
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Process Validation Engineer
Only for registered members Round Lake, Illinois, , United States
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Lab Equipment Validation Engineer
Only for registered members Round Lake
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Validation Engineer
Only for registered members Kenosha
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Validation Engineer
Only for registered members Des Plaines
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Validation Engineer
Only for registered members Kenosha
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Validation Engineer
Only for registered members South Elgin
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Validation Engineer
Only for registered members Kenosha
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Validation Engineer
Only for registered members Buffalo Grove
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Validation Engineer
Only for registered members Kenosha, WI
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Validation Engineer
Only for registered members Kenosha
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Validation Engineer
Only for registered members Wood Dale
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Validation Engineer
Only for registered members South Elgin
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Validation Engineer
Only for registered members South Elgin
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Validation Engineer
Only for registered members Kenosha
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Validation Engineer
Only for registered members Buffalo Grove
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Validation Engineer
Only for registered members Buffalo Grove