Senior Manager Validation

ACE Partners; Indianapolis (IN); Hybride; USD 162 000 - 198 000; Plein temps

Résumé du poste

ACE Partners in Indianapolis is seeking a Senior Manager, Process Validation to lead a globally dispersed validation engineering team. You will shape validation strategy across the manufacturing network and ensure equipment, facilities, utilities, automated systems, processes, and cleaning are qualified to GMP standards.

Reporting to the Director of Validation, you will drive science- and risk-based approaches to validation, oversee Site Validation Master Plans, and review protocols such as

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Validation engineering

cGMP experience

People management

Customer-facing experience

Lean Sigma

Formation

Bachelor's degree in Engineering or Computer Science

Outils

ISO 13485

EU GMP

21 CFR Part 820

Description du poste

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

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

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