CSV Engineer​/Validation Engineer

Responsibilities

• Execute Computer System Validation activities for Electronic Batch Record (E ) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11
• Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans in alignment with GAMP 5 principles
• Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope
• Participate in execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support
• Support validation of interfaces between PLC/SCADA systems and MES/E  platforms to ensure data integrity and accurate batch execution
• Maintain organized, inspection-ready validation documentation and support change control and periodic review activities for validated E  systems

• Bachelor A9s degree in Engineering, Computer Science, Life Sciences, or a related technical field
• 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment, supporting MES and/or Electronic Batch Record (E ) systems
• Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
• Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
• Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, Automation) and support system interfaces with PLC/SCADA-controlled equipment