Job Description:

• Contribute to Life Science projects for Antaes Asia clients.
• Lead the review, closure, and follow-up of I/O and Loop Check qualification protocols.
• Identify and track discrepancies found during loop checks (e.g., wiring errors, signal scaling issues, or hardware faults) and drive them to closure with the electrical and instrumentation (E&I) teams.
• Ensure that every physical instrument correctly communicates with the DeltaV system according to the P&IDs and Functional Specifications.
• Execute qualification deliverables for DeltaV coding, including Phase Logic, Module testing, and Graphics verification.
• Perform on-site software testing and dry runs during the Water Batching/Startup phases to ensure code aligns with process requirements.
• Manage software versions and formal Change Controls during the transition from the "build" phase to the "validated" state.
• Author and manage Pre-Execution documents (e.g., Test Scripts, User Requirement Specifications, Functional Design Specs).
• Compile post-execution summary reports, ensuring all "As-Built" documentation is accurate and compliant with Data Integrity standards.
• Maintain the automation validation master file to be ready for regulatory inspections (FDA/EMA).
• Contribute to the promotion of Antaes services on top of assistance provided to clients.

Job Requirements:

• Bachelor’s Degree in Chemical, Electrical, Biomedical, or related Engineering field.
• 2–5 years of CQV experience in the pharmaceutical industry
• Strong understanding of GAMP 5, S88/S95 standards, and 21 CFR Part 11
• Direct experience with Emerson DeltaV.
• Ability to manage multiple "open loops" and drive vendors/contractors to document closure.
• 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, in English - to coordinate and liase with English speaking counterparts.