Sr. Validation & Compliance Engineer

• Duration: 6+ months contract
• Pay rate: up to $57/hr
• Job Location: Indianapolis, IN (100% onsite)
• Schedule: M-F, 1^st shift
• Job#: bh19049

• Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities
• Author and review qualification documents, test scripts, deviation reports, and summary reports
• Perform risk-based commissioning and qualification activities in compliance with FDA, EMA, GMP, and internal quality standards
• Partner closely with engineering, quality assurance, validation, and manufacturing teams throughout the CQV lifecycle
• Support technology transfer activities, process validation efforts, and manufacturing handoff
• Participate in deviation investigations, CAPA implementation, and continuous improvement initiatives
• Ensure validation documentation is inspection-ready and aligned with regulatory expectations

• Strong hands-on experience developing and executing IQ/OQ/PQ protocols for pharmaceutical manufacturing equipment, utilities, and facilities.

• Deep understanding of FDA, EMA, GMP, and internal quality standards, including deviation investigations, CAPA management, validation documentation, and audit readiness.

• Proven ability to coordinate with engineering, QA, validation, and operations teams throughout the full CQV lifecycle, including technology transfer and process validation activities.

• 3–10+ years of CQV experience within pharmaceutical manufacturing environments
• Experience supporting GMP-regulated operations
• Strong technical writing and documentation skills
• Familiarity with risk-based validation methodologies
• Excellent communication and cross-functional collaboration abilities

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