CSV Engineer

CSV Engineer
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CSV Engineer

Asia - Singapore
Industrial Engineering and Life-Science
Permanent
October 9, 2025
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About the role

Job 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 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 case 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.
  • Any other tasks assigned
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Job 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 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 case 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.
  • Any other tasks assigned
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Your profile

This is some text inside a div block.

Job Requirements:

  • Degree in Engineering, Biotechnology, Life Sciences, or an equivalent field
  • At least 1 year of experience with the Emerson DeltaV system—software code review.
  • Hands-on experience with the validation lifecycle of computer systems and GAMP 5 is required.
  • Experience and knowledge of CSV in startups, as well as experience with brownfield projects in both operational technology and information technology systems, is a plus
  • Experience with Siemens PLC systems is a plus
  • Candidates must be highly motivated, able to work both independently and as part of a team, and possess strong organizational and verbal and written communication skills
  • Excellent communication skills, both written and verbal

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 15 consulting firms in Switzerland. We have more than 300 experienced engineers who share our passion.

 

With offices in Switzerland, Singapore, Hong Kong, and France, we support our clients and international clients by providing services in the following areas:

  • Organizational and Transformation Consulting
  • Industrial Engineering
  • Information Systems Management

 

When you join our team, you’ll discover:

  • A dynamic team with a startup mindset
  • Personalized support and guidance as your career progresses
  • Challenges to help you grow your network
  • Events: team-building activities, meetups, workshops, Winter Event …
  • A company certified by @HappyAtWork with a strong commitment to CSR (Ecovadis Gold Medal 2023)

APPLY
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CSV Engineer

Asia - Singapore
Industrial Engineering and Life-Science
Permanent

About the role

This is some text inside a div block.

Job 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 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 case 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.
  • Any other tasks assigned
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Your profile

This is some text inside a div block.

Job Requirements:

  • Degree in Engineering, Biotechnology, Life Sciences, or an equivalent field
  • At least 1 year of experience with the Emerson DeltaV system—software code review.
  • Hands-on experience with the validation lifecycle of computer systems and GAMP 5 is required.
  • Experience and knowledge of CSV in startups, as well as experience with brownfield projects in both operational technology and information technology systems, is a plus
  • Experience with Siemens PLC systems is a plus
  • Candidates must be highly motivated, able to work both independently and as part of a team, and possess strong organizational and verbal and written communication skills
  • Excellent communication skills, both written and verbal
Our positions are open to individuals who have been recognized as workers with disabilities. T&S Group promotes diversity and equality in the workplace. All qualified male and female candidates are considered for employment on an equal basis.

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 15 consulting firms in Switzerland. We have more than 300 experienced engineers who share our passion.

 

With offices in Switzerland, Singapore, Hong Kong, and France, we support our clients and international clients by providing services in the following areas:

  • Organizational and Transformation Consulting
  • Industrial Engineering
  • Information Systems Management

 

When you join our team, you’ll discover:

  • A dynamic team with a startup mindset
  • Personalized support and guidance as your career progresses
  • Challenges to help you grow your network
  • Events: team-building activities, meetups, workshops, Winter Event …
  • A company certified by @HappyAtWork with a strong commitment to CSR (Ecovadis Gold Medal 2023)