ANTAES ASIA PTE. LTD. is seeking a CSV Engineer to contribute to Life Science projects by ensuring compliance with GXP standards and providing quality oversight in computerized systems. Candidates should have experience with validation life cycles and strong communication skills
Job Summary
The role involves contributing to Life Science projects by providing quality oversight in computerized system life cycles.
Candidates must ensure compliance with GXP standards, Data Integrity, and 21CFR Part 11 while acting as a Subject Matter Expert.
Responsibilities include generating, reviewing, and executing protocols for initial validation programs related to GXP computer systems.
Matching Summary
Match Score: 85
ANTAES ASIA PTE. LTD. is seeking a CSV Engineer to contribute to Life Science projects by ensuring compliance with GXP standards and providing quality oversight in computerized systems. Candidates should have experience with validation life cycles and strong communication skills.
Skills & Requirements
Must-have
GAMP 5 validation life cycle experience
Emerson DeltaV software coding review
21CFR Part 11 compliance knowledge
Data integrity and CSV plan execution
Qualification protocol generation and review
Nice-to-have
Siemens PLC system experience
Start-up and brownfield project background
Cross-functional team collaboration skills
Strong written and oral communication in English
Experience with IT systems like Maximo or ERP
Key Requirements
Diploma in Engineering, Biotechnology, or Life Science
Minimum 1 year experience with Emerson DeltaV system
Hands-on experience in Validation life cycle of computer systems