CSV Validation Engineer
6 days ago
Responsibilities Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11. Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert Generate, review and execute protocols/test cases for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification. Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc. Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope in a Biologics manufacturing facility. Any other tasks assigned by Line Manager. Qualifications Minimum bachelor's degree or higher in Science or Engineering or equivalent with at least 3 years of relevant work experience Minimum 1 year experience with Emerson DeltaV system – software coding review. Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus Hands-on experience in Validation life cycle of computer systems is a must. Experience in Siemens PLC system is a plus Good communication skills Excellent team player willing to work for the common goal Knowledge of pharmaceutical regulatory requirements (GMP) is essential Shows a high level of tenacity to ensure closure of issues. Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met. #J-18808-Ljbffr
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Csv Validation Engineer
2 weeks ago
Singapore VALINA SERVICES PTE. LTD. Full timeAs a Consultant, you will be working for our client in the respect of the applicable regulations and quality procedures and could be required to: Main Responsabilities: - Be responsible for preparing and executing test documentation for computerized systems. You should have excellent understanding of 21 CFR Part 11, 21 CFR Part 820, ISO 13485, and GAMP 5...
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Singapore AMTSOL Export Engineering Private Limited Full timeCSV (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...
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Validation Engineers
6 days ago
Singapore TG Singapore Full timeValidation 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,...
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CSV Engineer
4 days ago
Singapore ANTER CONSULTING PTE. LTD. Full timeRole Overview We are seeking a Junior CSV Engineer to join Anter to support Computer System Validation (CSV) activities for pharmaceutical clients in Singapore. The role involves assisting with validation execution, documentation, and compliance to ensure systems meet regulatory and quality standards. Key Responsibilities Assist in the preparation,...
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Computer Systems Validation
4 days ago
Singapore ENFACTUM PTE. LTD. Full time**Responsibilities** - Develop and implement strategies for the validation of computer systems in compliance with domestic and international regulations. - Prepare and maintain all necessary validation documents, including validation master plans, validation plans, and risk assessments. - Execute validation protocols and prepare validation summary reports. -...
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CSV Engineer
2 weeks ago
Singapore ANTER CONSULTING PTE. LTD. Full time $40,000 - $80,000 per yearRole Overview:We are seeking a Junior CSV Engineer to join Anter to support Computer System Validation (CSV) activities for pharmaceutical clients in Singapore. The role involves assisting with validation execution, documentation, and compliance to ensure systems meet regulatory and quality standards.Key Responsibilities:Assist in the preparation, execution,...
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CSV Engineer
1 week ago
Singapore Coalesce Management Consulting Full timeOverview 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....
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Singapore Advanced Manufacturing Tech Solutions (AMTSOL) Full timeJob Title: CSV (Computer System Validation) Engineer - QualityLocation: Tuas, SingaporeIndustry: Life Sciences / Pharmaceutical ManufacturingRole 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...
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CSV QA Expert
1 week ago
Singapore Manpower Singapore Full timeOverview 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...
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Singapore Advanced Manufacturing Tech Solutions (AMTSOL) Full time $60,000 - $120,000 per yearJob Title: CSV (Computer System Validation) Engineer - QualityLocation: Tuas, SingaporeIndustry: Life Sciences / Pharmaceutical ManufacturingRole 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...
