Computer Systems Validation(CSV) Manager- Pharma/BioPharma Capital Projects

1 week ago

Singapore Process Engineering Specialists Full time

Overview Direct message the job poster from Process Engineering Specialists PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on delivering high quality outcomes for multinational clients. We are currently looking for CSV Manager- Projects to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry. Responsibilities Lead CSV initiatives for large CAPEX projects globally (minimum 15 years of experience). Serve as the critical link between CQV, Automation and IT/OT teams. Develop and implement Computer System Validation (CSV) programs, strategies, tools, and templates aligned with project C&Q and OT strategies. Provide CSV leadership and direction to project and program teams to ensure compliant system delivery. Author and review validation documents including CSV Plans, Reports, and Requirement Traceability Matrices (RTMs). Oversee vendors and automation partners to ensure delivery of fully compliant computerized systems. Ensure all automation documentation meets qualification and regulatory standards (GAMP 5, QMS). Support integrated testing across FAT, SAT, IQ, and OQ stages through collaboration with C&Q and automation teams. Identify risks and develop mitigation strategies; drive root-cause investigations and corrective actions for non-conformances. Ensure creation of supporting artefacts (SOPs, BCPs, access control) to maintain compliance with IS and CSV requirements. Conduct data analysis to support validation decisions and escalate significant compliance changes during project execution. Perform regular inspections and training oversight to maintain high standards in C&Q and automation activities. Qualifications At least 15 years experience leading CSV initiatives for large CAPEX projects globally. Experience with being the critical link between CQV, Automation and IT/OT Teams. Proven ability to develop and implement CSV programs, strategies, tools, and templates aligned with project C&Q and OT strategies. Strong leadership and communication skills to direct project and program teams. Experience with authoring and reviewing CSV documentation (Plans, Reports, RTMs). Familiarity with regulatory standards (GAMP 5, QMS) and qualification processes. Experience coordinating with vendors and automation partners to ensure compliant systems. How to apply If you’d like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony ( ). For the latest jobs and projects, follow PES on LinkedIn: PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role. #J-18808-Ljbffr

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