CSV (Computer System Validation) Engineer Quality Oversight

2 days ago


Singapore AMTSOL Export Engineering Private Limited Full time

CSV (Computer System Validation) Engineer Quality Oversight Join to apply for the CSV (Computer System Validation) Engineer Quality Oversight role at Advanced Manufacturing Tech Solutions Job Title: CSV (Computer System Validation) Engineer - Quality Location: Tuas, Singapore Industry: Life Sciences / Pharmaceutical Manufacturing Role Overview We are looking for a Computer System Validation (CSV) Engineer with hands‐on experience in validation documentation, test execution, and QA oversight support for regulated GxP systems. The ideal candidate will have strong grounding in validation lifecycle activities from URS through summary report and the ability to ensure compliance with internal quality standards and global regulatory expectations (GAMP 5, 21 CFR Part 11, Annex 11). Key Responsibilities Develop and execute test cases, test scripts, and validation protocols (IQ, OQ, PQ) in accordance with approved procedures. Prepare validation deliverables URS, Validation Plan, Traceability Matrix, Test Summary Reports, and Deviations. Support and coordinate validation testing activities under QA oversight. Ensure all documentation and test evidence meet data integrity (ALCOA+) and GxP compliance requirements. Participate in defect tracking, test incident resolution, and retest documentation. Collaborate with QA validation teams during review and approval of CSV deliverables. Contribute to change control, periodic review, and system revalidation activities. Maintain accurate audit‐ready documentation for all validation activities. Qualifications and Requirements Bachelor's degree in Engineering, Computer Science, Life Sciences, or related discipline. 3‐6 years of experience in Computer System Validation within GxP‐regulated environments. Proven experience in test case drafting, execution, and validation reporting. Exposure to validation of systems such as MES, LIMS, DCS/PLC, ERP, or other computerized systems. Sound understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles. Strong documentation and analytical skills. Ability to work collaboratively with QA, IT, and Engineering functions. #J-18808-Ljbffr



  • Singapore Celestica Full time

    Req ID: 119781 Remote Position: Hybrid Region: Asia Country: Singapore State/Province: Serangoon North **Summary**: **Detailed Description**: Performs tasks such as, but not limited to, the following: - Develops and executes validation plans, deliverables, and procedures that are consistent with the Celestica standards and the industry validation...


  • Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    We are currently expanding our team within our Life Sciences Division team and are looking for a CSV Engineer to support projects on site with a client. The following are key responsibilities: Design, develop, and execute of CSV strategies for DeltaV systems, ensuring alignment with regulatory requirements and project timelines. Collaborate with...


  • 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...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    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 consistently delivering high quality outcomes for our multinational clients....

  • CSV QA Expert

    2 weeks ago


    Singapore Manpower Singapore Full time

    Overview CSV QA Expert (Pharma/ Validation/ GAMP)– role at Manpower Singapore . Location: Tuas Industry: Pharmaceutical Salary: Up to $8,000 depending on experience Be part of building a next-gen, digitalized manufacturing facility in Singapore using advanced tech like AGVs, cobots, and cloud-based systems. Job Summary To ensure that computerized systems...

  • CSV QA Expert

    2 days ago


    Singapore Manpower Singapore Full time

    Overview CSV QA Expert (Pharma/ Validation/ GAMP)– role at Manpower Singapore . Location: Tuas Industry: Pharmaceutical Salary: Up to $8,000 depending on experience Be part of building a next-gen, digitalized manufacturing facility in Singapore using advanced tech like AGVs, cobots, and cloud-based systems. Job Summary To ensure that computerized systems...

  • Csv Engineer

    2 weeks ago


    Singapore No deviation Pte Ltd Full time

    No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services. We strongly uphold our core...

  • Validation Engineers

    2 weeks ago


    Singapore TG Singapore Full time

    Validation Engineers – Temperature Mapping & Laboratory Systems (CSV)Direct message the job poster from TG Singapore We are looking for Validation Engineers to join a leading project in Tuas, with opportunities in two specialized areas: Temperature Mapping Responsibilities Plan and execute temperature mapping studies for chambers (refrigerators, freezers,...

  • CSV QA Expert

    2 weeks ago


    Singapore Manpower Staffing Services Full time

    CSV QA Expert (Pharma/ Validation/ GAMP)Salary Up to $8,000 depending on experience Location : Tuas Industry : Pharmaceutical Be part of building a next-gen, digitalized manufacturing facility in Singapore using advanced tech like AGVs, cobots, and cloud-based systems. Job Summary To ensure that computerized systems used in manufacturing and quality control...

  • CSV Engineer

    2 days ago


    Singapore Coalesce Management Consulting Full time

    Overview We are seeking a skilled CSV Engineer to provide quality oversight and validation support across the computerized system lifecycle within a biologics manufacturing environment. This role requires deep understanding of GxP standards, data integrity, and regulatory compliance, with hands-on experience in validating complex automation and IT systems....