
CSV Engineer
10 hours 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
3 weeks ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities:Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and...
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Senior Csv Engineer
2 hours ago
Singapore PM Group Full time**Senior CSV Engineer**: - Contract - Onsite - Singapore, Singapore - CQV - 7316 - SGD **Overview - We have an immediate requirement for 2 - **CSV Specialists **to join a highly skilled PM Group team based on a client site. **Responsibilities **Day to day activities include the following**_:_** - Commissioning and Qualification of hardware and associated...
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CSV Engineer
6 days ago
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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Senior Csv Engineer
1 week ago
Singapore PM Group Full time: We have an immediate requirement for 2 **CSV Specialists **to join a highly skilled PM Group team based on a client site. : **Day to day activities include the following**_:_** - Commissioning and Qualification of hardware and associated software to support Utility/Process equipment. This includes PLC & SCADA plus interfaces with networks. - Documentation...
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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...
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Csv Engineer
2 hours ago
Singapore COMBUILDER PTE LTD Full time**Responsibilities**: - Lead and execute Computerized Systems Validation (CSV) activities, including planning, testing, documentation, and reporting. - Collaborate closely with the Compliance Engineering team to support commissioning, qualification, and validation (CQV) activities. - Prepare, review, and approve qualification documentation (URS, DQ, FAT,...
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Csv Engineer
2 days ago
Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full timeWe are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while supporting continuous improvement...
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Csv Engineer
2 hours ago
Singapore PSC BIOTECH PTE. LTD. Full timeOur esteemed client is seeking highly qualified and skilled CSV Engineers, both at the Senior and Junior levels, to provide essential support for routine and project-based Computer System Validation (CSV) activities. As a CSV Engineer, you will be instrumental in ensuring the compliance, reliability, and efficiency of computer systems utilized across diverse...
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Csv Engineer
2 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time**Position: CQV/CSV Engineer in Singapore** **Job Description**: We are currently expanding our team and are looking for a **Computer Systems Validation Engineer **for our project on site with our client. You will be responsible for planning, writing, implementing and reviewing Computer Systems Validation protocols in place within highly regulated...
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CSV Validation Engineer
1 week ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeRoles & Responsibilities 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...