
CSV Engineer
1 day ago
We are seeking an experienced CSV Engineer to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with 21 CFR Part 11, Annex 11, GAMP 5 , and collaborating with cross-functional teams for successful project delivery.
Key Responsibilities- Develop and execute validation plans, test plans, and qualification protocols ( IQ, OQ, PQ, PPQ ) for lab, manufacturing, and automation systems.
- Perform CSV deliverables including URS, risk assessments, traceability, and test scripts.
- Ensure compliance with data integrity (ALCOA+), 21 CFR Part 11, and GMP guidelines .
- Manage change control, deviations, CAPA, and risk assessments (pFMEA/dFMEA) .
- Coordinate with QA, QC, IT, and Engineering for validation activities and project timelines.
- Maintain accurate documentation for audits and regulatory inspections.
- Apply GAMP 5, V-Model, and Agile methodologies in validation lifecycle.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
- 3–6 years' experience in CSV within pharma/biotech/life sciences.
- Strong knowledge of validation protocols (IQ/OQ/PQ/PPQ), data integrity, audit trails, and compliance standards .
- Exposure to Automation, DeltaV, PLCs, or MES systems will be a strong advantage.
- Hands-on with lab/analytical systems, LIMS, or automation control systems preferred.
- Excellent problem-solving and documentation management skills.
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Csv Engineer
2 days ago
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CSV Engineer
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Singapore Antaes Asia Full timeOverview Join to apply for the CSV Engineer role at Antaes Asia . 4 days ago Be among the first 25 applicants. Responsibilities Contribute to Life Science projects for Antaes Asia clients. Work with cross-functional teams in providing Quality oversight in computerized system life cycle procedures and ensure compliance with GXP standards and company policies...
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CSV Engineer
1 week ago
Singapore ANTAES ASIA PTE. LTD. Full timeJob Description: Contribute to Life Science projects for Antaes Asia clients Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV...
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CSV Engineer
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Pharma Csv Engineer
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Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full timePES 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...
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Senior Csv Engineer
2 days ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeThis position is responsible for the validation of automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus and also have thermal mapping experience. In this role, the engineer has to work in accordance with the company’s policies and procedures to ensure validation is performed in...
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CSV Engineer
4 days ago
Singapore PSC Biotech Full timeBoon Lay Way, Singapore | Posted on 09/18/2025Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems. Perform risk assessments and impact analysis related to system validation. Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality Assurance,...
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CSV Validation Engineer
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Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeResponsibilities 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...
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Associate Csv Engineer
2 days ago
Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time**Job description** **Responsibilities**: - Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. - Responsible for preparation of CSV documents and protocols, perform execution for automated equipment...