
CSV Engineer
5 days ago
- Develop 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, and Manufacturing teams to support system qualification and validation activities.
- Manage change control and deviation investigations related to validated systems.
- Support audits and inspections by regulatory authorities.
- Maintain validation documentation and ensure traceability throughout the system lifecycle.
- Bachelor's degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
- 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
- Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
- Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional teams.
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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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CSV Engineer
4 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
7 days 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
2 weeks ago
Singapore ANTER CONSULTING PTE. LTD. Full time**About the Role**: We are hiring a CSV Engineer to support pharmaceutical manufacturing projects in Singapore. The role focuses on validating GxP computerised systems to ensure compliance with relevant regulatory and data integrity standards across the project lifecycle. **Key Responsibilities**: - Author and review validation documentation (URS, FS, RTM,...
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CSV Engineer
6 days 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
12 hours 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
12 hours 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
6 days 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...
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CSV Engineer
4 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
12 hours ago
Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time**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 and/or control systems,...