Senior Global Validation Engineering Lead

RXinsider LTD.; Greenfield (IN); On-site; USD 117,000 - 150,000; Full time

Job summary

West Pharmaceutical Services is seeking a senior Validation Engineering Leader to drive strategy and execution across the Global Technical Operations network. You will oversee qualification activities for equipment, facilities, and processes, ensuring GMP compliance and risk-based approaches.

The role requires 10 years in validation engineering within a cGMP setting, strong ISO 13485/EU GMP knowledge, and the ability to collaborate across global teams while guiding site validation programs and

Qualifications

• Must have 10 years of validation engineering experience in a cGMP regulated industry.
• Post graduate experience (10 years) in high-volume manufacturing, ideally medical device/pharma.
• Strong knowledge of ISO 13485, EU GMP, CFR Part 820 and related standards.

Responsibilities

• Lead a globally dispersed Validation Engineering team, defining strategy and execution across the Global Technical Operations network.
• Harmonize and implement validation standards and procedures based on regulations and industry practices.
• Oversee creation and review of validation master plans, protocols, and reports across programs.

Skills

Validation leadership

Global teamwork

Regulatory compliance

Process validation

Education

Bachelor's degree in Computer Science or Engineering

Tools

cGMP experience

ISO 13485 knowledge

Documentation systems

Job description

West Pharmaceutical Services is seeking a senior Validation Engineering Leader to drive strategy and execution across the Global Technical Operations network. You will oversee qualification activities for equipment, facilities, and processes, ensuring GMP compliance and risk-based approaches.

The role requires 10 years in validation engineering within a cGMP setting, strong ISO 13485/EU GMP knowledge, and the ability to collaborate across global teams while guiding site validation programs and