Lead Validation Engineer

Location: Minneapolis, Minnesota

Job Summary

SRG is seeking an experienced Lead Validation Engineer to support the Facilities, Utilities, and Equipment Validation (FUEV) workstream for a Centrifuge Replacement Project within a GMP biopharmaceutical manufacturing environment. The successful candidate will own the complete GxP validation lifecycle, including protocol development, execution, deviation management, and project closeout activities for major equipment replacement projects. This individual will serve as the primary technical liaison between the project team and the client's QA, Engineering, Operations, and Validation groups.

Equipment Scope

• Bioreactor Transfer Panel
• Automation and Controls Upgrades

Key Responsibilities

Protocol Development

• Author and revise validation documentation in Kneat Gx, including Risk Assessments, DQ, SAT, IQ, OQ, and PQ protocols.
• Develop traceability matrices and define testing scope based on risk assessments.
• Review engineering drawings, P&IDs, specifications, and vendor documentation.
• Collaborate with Engineering, QA, Validation, and Cleaning Validation teams.
• Support Factory Acceptance Testing (FAT) reviews and witness vendor testing activities.
• Lead on-site IQ/OQ/PQ execution activities.
• Coordinate validation testing with Operations, Engineering, and QA teams.
• Supervise validation technicians and ensure accurate execution and documentation in Kneat Gx.
• Perform equipment, utility, process, controls, and instrumentation verification testing.
• Manage deviations, investigations, CAPAs, and protocol revisions.
• Provide routine project status updates to stakeholders.
• Support Qualification Summary Report (QSR) preparation.
• Ensure completion of all testing, documentation, and deviation closure.
• Verify traceability and production release readiness.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 8+ years of GMP validation experience within pharmaceutical or biotechnology manufacturing.
• Extensive experience authoring and executing IQ/OQ/PQ protocols.
• Experience supporting FAT and SAT for complex process equipment.
• Proficiency with Kneat Gx or similar electronic validation systems.
• Ability to read and interpret P&IDs, engineering drawings, and functional specifications.
• Working knowledge of PLC-controlled equipment, CIP/SIP systems, instrumentation, and GMP regulations.
• Strong documentation, coordination, communication, and problem-solving skills.