CSV Engineer

Roles & Responsibilities

Job Description:

• 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 and procedures.
• Provide guidance and support to establish systems for ensuring Data integrity, compliance with 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 cases 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 documentation 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 Requirements:

• Diploma in Engineering, Biotechnology, Life Science, or equivalent.
• Minimum 1 year experience with Emerson DeltaV system - software coding review.
• Hands-on experience in Validation life cycle of computer systems/GAMP 5 is a must.
• Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology/Information Technology systems is a plus.
• Experience in Siemens PLC system is a plus.
• Candidate must be highly motivated, be able to work independently as well as in a team, and have good organizational and oral and written communication skills.
• Excellent communication skills, both written and verbal.