CSV Engineer
5 days ago
Responsibilities 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. Requirements 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. #J-18808-Ljbffr
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CSV Engineer
1 week 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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CSV Engineer
2 weeks 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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CSV Engineer
1 day ago
Singapore ANTER CONSULTING PTE. LTD. Full timeRoles & Responsibilities Role 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...
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CSV Engineer
1 week 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
12 hours 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
5 days ago
Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time $120,000 - $180,000 per yearWe 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...
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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
5 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 to CSV Plan...
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Csv Engineer
1 week 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
4 days ago
Singapore GAM-X ENGINEERING SERVICES PTE. LTD. Full time $80,000 - $120,000 per yearResponsibilities:Provides expertise in performing Computerized Systems Validation.Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations GxP, 21CFR11, etc.)Perform collaborative work with the Compliance Engineering team on...