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.
