CSV Engineer
CSV Engineer
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.
Your profile
Job Requirements:
- Diploma in Engineering, Biotechnology, Life Science or equivalent.
- At least 1 year of experience with the Emerson DeltaV system—software code review.
- Hands-on experience in Validation life cycle of computer systems/ GAMP Â 5 is a must.
- Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus.
- Experience in Siemens PLC system is a plus.
- Candidates must be highly motivated, able to work both independently and as part of a team, and possess strong organizational and oral and written communication skills.
- Excellent communication skills, both written and verbal, in English - to coordinate and liase with English speaking counterparts.
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)
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- Check and validate the accuracy of definition data when re-using it.
- Identify and coordinate requirements for geometric analysis, composition, material condition, assembly and marking.
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CSV Engineer
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.
Your profile
Job Requirements:
- Diploma in Engineering, Biotechnology, Life Science or equivalent.
- At least 1 year of experience with the Emerson DeltaV system—software code review.
- Hands-on experience in Validation life cycle of computer systems/ GAMP Â 5 is a must.
- Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus.
- Experience in Siemens PLC system is a plus.
- Candidates must be highly motivated, able to work both independently and as part of a team, and possess strong organizational and oral and written communication skills.
- Excellent communication skills, both written and verbal, in English - to coordinate and liase with English speaking counterparts.
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)
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