Lead Validation Engineer
$124,449–$150,803 year
On-siteIndianapolis, Indiana, United States
Job Summary
Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs. Draft, review, and execute commissioning, qualification, and validation documents and protocols supporting highly specialized facility, utility, analytical, and process equipment. Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments. Own and manage complex validation programs, ensuring timely execution of protocols, reports, and lifecycle documentation. Lead deviation investigations, support root cause analysis, and drive continuous improvement projects that enhance compliance and operational readiness. Mentor validation engineers and cross-functional team members while supporting regulatory inspections and internal audits.
Required Qualifications
- BS or MS in a scientific or engineering discipline, or equivalent work experience
- 5+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment
- 5+ years of validation experience within a GMP-regulated environment
- Demonstrated experience leading complex validation programs and cross-functional initiatives
- Strong technical writing and document review skills
- Deep understanding of regulatory expectations for validation, lifecycle management, and risk management
- Strong leadership, decision-making, and problem-solving skills
- Ability to work independently while effectively influencing cross-functional teams
- Excellent communication, organization, and project management capabilities
- Proven ability to prioritize multiple initiatives in a fast-paced GMP environment
- Broad validation knowledge across areas such as process validation, cleaning validation, computer system validation, equipment qualification, and QC assets
- High level of professional ethics, integrity, and ability to maintain confidential information
- Ability to apply AI to improve team execution and decision-making
- Ability to occasionally lift and/or move up to 30 pounds
- Ability to work in a GMP cleanroom environment
- Ability to wear protective clothing
- Ability to handle radioactive materials
- Close vision
- Distance vision
Desired Qualifications
- Prior experience mentoring engineers or leading project workstreams
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