Senior Manager Validation (Greater Indianapolis)

Senior Manager, Process Validation | Up to $180,000 + 20% bonus

Location: Hybrid (3 days onsite), Midwest US. Relocation assistance available.

The role

Reporting to the Director of Validation, you'll lead a globally dispersed validation engineering team. You'll shape validation strategy across the manufacturing network and make sure equipment, facilities, utilities, automated systems, processes, and cleaning are qualified to GMP standards.

Key responsibilities

• Lead, develop, and set direction for a global validation engineering team
• Harmonize validation standards and procedures across multiple sites
• Drive science- and risk-based approaches to validation
• Oversee Site Validation Master Plans, and review and approve FAT, SAT, IQ, OQ, and PQ documentation, including third-party protocols
• Support technology transfer programs into operations
• Represent validation in customer meetings and work across functions to make sure new processes meet business needs
• Keep validation status current through periodic reviews and compliant documentation

What you'll bring

• Degree in Engineering, Computer Science, or a related field
• 10+ years of validation engineering experience in a cGMP environment
• 10+ years in high-volume manufacturing, ideally medical device or pharma
• Strong knowledge of ISO 13485, EU GMP, and 21 CFR Part 820
• Previous people management experience and a track record of influencing across a matrixed organization
• Customer-facing experience
• Plastics processing, computer system validation, and Lean Sigma experience are a plus
• Willing to travel as needed