Sr Validation Engineer

Job Description

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.