Senior Manager, Process Validation

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Requisition

Date:
Aug 19, 2026

Location:

Greenfield, IN, US, 46140

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Reporting to the Director of Global Validation and Metrology Services, this role is responsible for contributing to the development and implementation of the validation engineering strategy for West Global Technical Operations whilst ensuring the qualification and validation of equipment, facilities, utilities, automated systems, processes and process cleaning procedures are carried out in accordance to GMP and relevant guidelines. This role will direct the application of resources within and across its functional responsibility to assist global sites in improving the manufacturing of products and develop the most optimum processes and solutions which meet or exceed West and/or customer requirements.

• Provide technical leadership and direction to a globally dispersed Validation Engineering team with responsibility for defining strategy, planning and execution of Validation activities within the Global Technical Operations network.
• Provide strategic leadership of long-term and intermediate goals the Global Technical Operations Network.
• Direct resources from functional responsibility for Validation in support of programs within the Global Technical Operations Network.
• Participate in the harmonization and implementation of Validation standards and procedures across the Global Technical Operations network based on current regulations, industry standards and industry practices.
• Drive innovative and efficient approaches to validation incorporating science and risk-based approach.
• Oversee the preparation, review, and approval of Site Validation Master Plans.
• Review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
• Oversight of third party generated protocols and reports in conjunction with program Quality representation.
• Fosters and encourages shared learning’s across the organisation e.g. system and technology best practices.
• Chair, schedule and minute validation meetings and participate in meetings when required.
• Perform periodic reviews of systems in order to maintain validation status.
• Support the set-up and maintenance of electronic validation documentation while ensuring the archiving and
  filing of hard copy validation documentation across all programs is compliant with site policies.
• Oversee the implementation of site validation strategies to meet customer and West needs.
• Work with all departments across the business to ensure that new processes meet their requirements.
• Play a key part in Global Technical Operations transfer programs to ensure flawless transition into Operations.
• Represent West at customer meetings to ensure that the needs of the business are met.
• Assist with the training and development of personnel at all levels…