Automation Engineer
C
Coalesce Management Consulting
📍 singapore, singapore, Singapore
Job Description
We are looking for a CSV / Automation Engineer with strong hands-on experience in Siemens PCS 7 to support the implementation, qualification and lifecycle management of automated manufacturing systems within a regulated GMP environment.
Key Responsibilities
- Support the design, configuration, testing and qualification of Siemens PCS 7 automation systems.
- Develop and review automation and CSV documentation, including URS, functional and design specifications, risk assessments, test protocols, traceability matrices and validation summary reports.
- Execute FAT, SAT, IQ, OQ and system integration testing for process control and automation systems.
- Ensure automated systems comply with GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and data integrity requirements.
- Review system configurations, alarms, interlocks, recipes, audit trails, user access controls and electronic records.
- Investigate system deviations a...