Senior Manager leading design and implementation of integration solutions for enterprise systems at Simpson Thacher. Collaborating with teams to enhance scalability, security, and reliability.
WS
Onsite Solution Architect – Validation & Testing
Posted 5 days ago
About the role
- Solution Architect managing validation activities for GxP computerized systems at West. Collaborating with cross-functional teams to ensure compliance with global regulatory requirements.
Responsibilities
- Handle various computer system validation activities for different cross functional programs across West Pharma.
- Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
- Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
- Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
- Participate in internal audits and regulatory inspections, providing validation rationale and documentation support.
Requirements
- Requires bachelor’s degree in computer science or Information Technology
- Minimum 3 years of relevant experience (preferably in Medical Device or Pharma validation of Software)
- Prior working knowledge on tools like SAP, QMS, LIMS
- Good understanding of GxP computerized system lifecycle principles (GAMP 5)
- Ability to guide cross-functional teams in integrating validation requirements during system implementation
- Prior knowledge on documentation review skills with attention to compliance, traceability, and audit readiness.
Benefits
- health insurance
- paid time off
- professional development programs
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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