Global Validation Leader, Manufacturing & Compliance

West Pharmaceutical Services, Inc; Greenfield (IN); On-site; USD 140,000 - 170,000; Full time

Job summary

West Pharmaceutical Services, Inc. in Greenfield, Indiana, is seeking a Senior Manager of Process Validation to lead a global validation engineering team and drive the strategy for equipment, facilities, utilities, and automated systems within Global Technical Operations.

You will oversee validation master plans, ensure regulatory compliance, and collaborate with customers and internal partners to optimize manufacturing processes and meet West’s standards for quality and performance.

Qualifications

• Must have 10 years of validation engineering experience in a cGMP regulated industry.
• Minimum 10 years post-graduate experience in a high-volume manufacturing environment, preferably medical device/pharma.
• In-depth knowledge of ISO 13485; EU GMP, CFR Part 820.

Responsibilities

• Provide technical leadership to a globally dispersed Validation Engineering team.
• Lead strategy, planning and execution of Validation within Global Technical Operations.
• Oversee Site Validation Master Plans and qualification/validation documentation.
• Collaborate across departments to ensure new processes meet requirements.
• Represent West at customer meetings and drive Lean Sigma initiatives.

Skills

People leadership

Strong communication

Project management

Regulatory knowledge

Travel readiness

Education

Bachelor's degree in Computer Science or Engineering

Tools

Validation software

Job description

West Pharmaceutical Services, Inc. in Greenfield, Indiana, is seeking a Senior Manager of Process Validation to lead a global validation engineering team and drive the strategy for equipment, facilities, utilities, and automated systems within Global Technical Operations.

You will oversee validation master plans, ensure regulatory compliance, and collaborate with customers and internal partners to optimize manufacturing processes and meet West’s standards for quality and performance.