Senior Software Validation Engineer, Manufacturing
About The Position
Automated Testing: Develop, implement, and maintain test scripts using appropriate tools to automate testing and regression testing for validated systems, increasing efficiency and repeatability. Process Documentation: Author, review, and approve validation documentation, including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Traceability Matrices (TM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR). Participate in internal and external audits (e.g., ISO, regulatory body inspections) as the CSV expert. Technical Skills: Proficiency in writing automation scripts in Python and using software testing tools to drive efficient, repeatable testing.
Requirements
- 5 years of experience in Software Quality Assurance AND Computer System Validation (CSV) in a regulated, design-controlled industry (e.g., Medical Devices, Pharmaceuticals, Biotechnology).
- Demonstrated, in-depth understanding of ISO 13485 (or strong experience with an equivalent quality standard like FDA 21 CFR Part 820 or 21 CFR Part 11).
- Exceptional technical writing skills with the ability to create clear, concise, and compliant validation documentation.
- Bachelor's degree in Computer Science, Engineering or a related technical field.
- Proficiency in writing automation scripts in Python and using software testing tools to drive efficient, repeatable testing.
- Hands-on experience with AI and LLM's
- Basic understanding of GxP or FDA 21 CFR Part 11
- Proven, hands-on experience validating commercial off-the-shelf (COTS) and configured software, specifically ERP systems (e.g., SAP, Oracle, NetSuite, etc.), LIMS, and complex spreadsheet validation.
Nice To Haves
- Current experience in an ISO 9001 environment is a plus.
Responsibilities
- Develop, implement, and maintain test scripts using appropriate tools to automate testing and regression testing for validated systems
- Author, review, and approve validation documentation, including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Traceability Matrices (TM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR).
- Participate in internal and external audits (e.g., ISO, regulatory body inspections) as the CSV expert.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
1,001-5,000 employees
