Computer System Validation (CSV) Engineer – PAS-X Upgrade Program
Title: Computer System Validation (CSV) Engineer – PAS-X Upgrade ProgramLocation: CASummarySeeking an experienced Computer System Validation (CSV) Engineer to support validation activities for a PAS-X upgrade program within a regulated biopharmaceutical manufacturing environment. The role involves executing validation deliverables using Kneat electronic validation workflows while applying GAMP 5 and risk-based validation methodologies. The ideal candidate will have hands-on experience with MES/PAS-X systems, regulated GxP environments, and manufacturing system upgrades.ResponsibilitiesSupport execution of validation activities for the PAS-X upgrade project under the guidance of the lead validation resource.Execute validation lifecycle activities using Kneat electronic validation workflows.Apply GAMP 5 principles and risk-based validation practices during planning, execution, and documentation activities.Prepare, review, and execute validation documents including protocols, test scripts, traceability matrices, and summary reports.Provide backup support to the lead validation resource and help accelerate project execution timelines.Support MES/PAS-X implementation and upgrade workstreams in regulated manufacturing environments.Collaborate with Quality, Manufacturing, Engineering, and IT teams to ensure successful validation execution.Ensure compliance with GxP requirements, company procedures, and regulatory standards.Support deviation investigations, issue resolution, and corrective action activities related to validation deliverables.Participate in system testing, validation reviews, and project meetings.Maintain accurate validation documentation within electronic quality systems.Perform additional related duties and assignments as required.RequirementsHands-on experience in Computer System Validation (CSV) within regulated GxP environments.Experience working with Kneat electronic validation platforms and workflows.Strong understanding of GAMP 5 guidelines and risk-based validation methodologies.Experience supporting manufacturing system upgrades, preferably involving PAS-X / Körber systems.Prior MES/PAS-X validation experience within biopharmaceutical or pharmaceutical manufacturing environments.Familiarity with validation lifecycle documentation including IQ/OQ/PQ and traceability practices.Strong technical documentation, analytical, and problem-solving skills.Ability to work effectively in fast-paced project environments with changing priorities.Strong communication and cross-functional collaboration skills.Bachelor’s degree in Computer Science, Information Systems, Engineering, or related field required.Master’s degree preferred.