Job description

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.

Job Summary

In this role, you will be responsible for overseeing computer system validation activities across a range of cross-functional programs at West Pharma. You will also lead the team in project management, ensuring the successful and timely delivery of projects

Essential Duties and Responsibilities

Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
Perform system impact assessments and risk assessments to define appropriate validation scope and strategy.
Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
Demonstrate strong understanding of computerized systems, their intended use, data flows, and system lifecycle to ensure appropriate validation controls are established.
Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
Ensure compliance with Data Integrity (ALCOA+) principles, including audit trails, access management, and electronic records controls.
Support deviation management, change control assessments, and periodic review activities for validated systems.
Participate in internal audits and regulatory inspections, providing validation rationale and documentation support.
Promote risk-based and CSA-aligned validation practices within project teams.
Provide mentorship and functional guidance to junior validation team members.

#LI-Hybrid #LI-SM

Education

Bachelor’s degree in computer science, or Information Technology.

Work Experience

Must have 5-8 years of relevant experience preferably in Medical Device or Pharma validation of Software

Preferred Knowledge, Skills and Abilities

Must understand tools like SAP, QMS, LIMS, validation or testing tools.
Ability to understand and apply AI technologies in both pharmaceutical and general business environments, with a focus on driving innovation, efficiency, and compliant decision-making.
Strong understanding of GxP computerized system lifecycle principles (GAMP 5, risk-based validation, CSA approach).
Working knowledge of global regulatory requirements including 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), and applicable GMP regulations.
Ability to interpret system functionality, data flows, and intended use to determine appropriate validation controls.
Sound knowledge of risk assessment methodologies and their application in validation strategy development.
Ability to guide cross-functional teams in integrating validation requirements during system implementation and changes.
Strong documentation review skills with attention to compliance, traceability, and audit readiness.
Effective communication skills to translate regulatory expectations into practical project requirements.
Ability to identify compliance gaps and recommend risk-based remediation strategies.
Capability to manage multiple validation activities in a structured and organized manner.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Shift

Occasional on-call work required
Prefer 12pm – 9pm India time. Willingness to work outside of these hours as needed.
Ability to work in a global and virtual environment and to effectively prioritize and execute tasks in a high-pressure environment.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.

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