Solution Architect, Validation & Testing

West Pharmaceutical Services, Inc; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

West Pharmaceutical Services, Inc is seeking a Solution Architect, Validation & Testing to lead GxP validation activities for cross-functional programs in Bengaluru. The role requires deep expertise in validation lifecycle, regulatory expectations, and collaboration with QA, IT, engineering and manufacturing teams.

Applicants should have 3+ years of experience in medical device or pharma software validation and hands-on knowledge of SAP, QMS, and LIMS tools.

Qualifications

• Bachelor's degree in computer science or information technology.
• 3 years of relevant experience in medical device or pharma software validation.
• Knowledge of GxP computerized system lifecycle and regulatory expectations.
• Familiar with 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity principles.

Responsibilities

• Lead validation activities for GxP computerized systems in compliance with 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 (URS, IQ/OQ/PQ, RTM, VSR).
• Demonstrate understanding of system lifecycle, data flows, and validation controls.
• Guide cross-functional teams to ensure validation requirements are integrated during implementation and changes.
• Ensure compliance with ALCOA+ data integrity and audit trails.

Skills

SAP

QMS

LIMS

GxP validation

Validation tools

Education

Bachelor's degree in CS/IT

Job description

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Title: Solution Architect, Validation & Testing

Requisition ID: 75936

Date: Sep 22, 2026

Location: Bengaluru, KA, IN

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 handling various computer system validation activities for different cross functional programs across West Pharma.

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 3 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.
• 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 andexecute 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 orderto apply to West, please send an email to [e-mail] . 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.