Sr Solution Architect,D&T, Validation & Testing

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…