Csv Consultant

Key Responsibilities: Deliver CSV consulting projects to support implementation of computerized systems (e.g., DeltaV, Siemens PCS7, Rockwell PLCs) in the Life Sciences clients with compliance of GxP and other relevant regulatory standards. Deliver CSV consulting projects to support OS upgrade (e.g., Windows 11 upgrade) for laboratory and manufacturing equipment. Draft, review and maintain CSV documentation such as URS, FDS, Risk Assessment, Audit Trail Assessments, ERES assessments, Data Security Assessment, Validation Plans, IOPQ Protocols, RTM and any other lifecycle management documents. Provide expert consultation to ensure compliance with current regulatory requirements (e.g., GAMP5, 21 CFR Part 11, Annex 11). Support system configuration and computerised system (CS) activities such as backup and restore, access management, etc. Manage stakeholders from cross-functional teams (IT, Quality, Engineering, Operations) to plan and implement validation activities. Collaborate with other stakeholders including IT/OT, automation and quality teams to deliver validation projects on schedule. Draft, revise and review SOPs, forms and related operational and maintenance documents. Requirements: Hold Bachelor’s degree in Life Sciences, Engineering or related field. Possess 2-4 years of experience in Computer System Validation (CSV), Automation, or related quality and compliance roles within a regulated environment (pharmaceutical, medical device, etc.) Familiar with CSV lifecycle management and automation systems validation. Had experience in leading a project from planning through execution and reporting. Able to manage stakeholders and deliverables within project timelines. Must be able to work independently and deliver results under minimal supervision. Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5). Preferably with experience in change, incident and problem management. Why Join Ork…