Software Validation Engineer

Merck-posted about 1 month ago
Full-time • Mid Level
Hybrid • Saint Louis, MO
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

As a Software Validation Engineer at MilliporeSigma, you will guide and direct validation projects for all Life Science digital products, applications, and computerized systems. You will serve as a subject matter expert, providing leadership on computerized systems validation, quality governance, and regulatory compliance, including travel for critical site support during inspections or major projects.

  • Lead the qualification and validation of diverse digital products, computerized systems, and software solutions, including Control Systems, Cloud-based solutions, and Operational Technology (OT)
  • Execute the full validation lifecycle (IQ, OQ, PQ, protocols, test scripts, infrastructure qualification, backup/restoration, and audit trail testing) in both GMP and Non-GMP environments
  • Ensure compliance with global regulatory guidelines including GAMP, QMS, 21 CFR Part 11, and Annex 11
  • Perform critical assessments (Risk, Functional Risk, Data Integrity, FMEA) to define requirements and controls prior to development and verify tested systems meet those standards
  • Review and approve validation documentation, including URS, Functional/Design Specifications, and Test Scripts for COTS and new products
  • Develop and manage core validation documents, such as Test Scripts/Protocols, Test Summary Reports, Traceability Matrices, and Validation Summary Reports
  • Manage quality system activities, including Operational Change Control, Deviation/CAPA management, customer complaint handling, and periodic review/re-validation
  • Act as the validation expert during audits, effectively presenting and explaining qualification documents and reports to regulatory agencies, internal/external auditors, and customers
  • Bachelor’s degree in Chemistry, Chemical Engineering, Computer Science, Biomedical engineering or other Life Science discipline
  • 5+ years of experience in software and/or computerized validation
  • Excellent written and verbal skills
  • Prior automation testing experience
  • Excellent computer skills and experience in Project Planning, Word, Excel, PowerPoint, SharePoint
  • Qualified systems and supported process validation, ensuring compliance with GMP, GCP, GLP, GAMP, and Part 11 regulations
  • Global travel based on the need of project and business
  • health insurance
  • paid time off (PTO)
  • retirement contributions
  • other perquisites
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Validation Engineer Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service