Senior Automation Engineer
No Deviation · Singapore
Job description
About the role
No Deviation, an engineering consultancy offering Commissioning Qualification Validation (CQV) and Quality, Compliance and Regulatory services, is hiring a Senior Automation Engineer in Singapore. The engineer supports automation system design, implementation, commissioning, qualification, troubleshooting and lifecycle management in a GMP-regulated pharmaceutical or biotechnology manufacturing environment, working with Manufacturing, Engineering, CQV, QA, IT/OT, vendors and project teams.
Key responsibilities
- Support design, configuration, testing, commissioning and qualification of automation and control systems, and troubleshoot issues related to equipment, process control, communication, alarms, interlocks, recipes and interfaces.
- Support new equipment installation, facility expansion, system upgrades and process improvement projects, including FAT, SAT, loop checks, I/O verification, alarm and sequence testing.
- Prepare automation validation documentation (URS, FDS, HDS, SDS, risk assessments, test protocols, traceability matrices, validation reports) and support IQ, OQ, PQ, CSV and qualification activities.
- Ensure compliance with GMP, GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity, and support deviation investigations, CAPA, change control and audit readiness.
- Maintain system documentation, backups, access control and configuration records, and support periodic reviews, disaster recovery and audit trail reviews.
- Provide technical guidance to junior engineers or technicians and collaborate with Manufacturing, Engineering, Maintenance, QA, QC, IT/OT and vendors.
Required profile
- Degree or diploma in Automation, Electrical, Mechatronics, Computer, Chemical Engineering or a related discipline.
- Minimum 5 to 8 years of automation engineering experience in pharmaceutical, biotechnology, medical device, chemical or GMP-regulated environments.
- Hands-on experience with PLC, SCADA, DCS, HMI, BMS, EMS or MES interfaces, and with GMP documentation, change control, deviation investigation and validation support.
- Strong troubleshooting, analytical and problem-solving skills, good communication and stakeholder management, and ability to manage multiple priorities.
Required skills
- Automation platforms such as Siemens, Rockwell/Allen-Bradley, DeltaV, Wonderware, iFIX, GE, Schneider, Emerson or equivalents.
- PLC logic, control sequences, alarm management, recipe management, batch control and equipment interfaces.
- Ability to read P&IDs, control narratives, electrical drawings, loop diagrams and I/O lists.
- Knowledge of GAMP 5, CSV, data integrity, 21 CFR Part 11 and EU Annex 11; OT networks, industrial protocols and cybersecurity are advantageous.
What we offer
- Generous leave policy.
- Comprehensive health and wellness coverage, including medical and dental.
- Professional development opportunities and an inclusive culture.
To apply, candidates submit their resume through the company's application form.
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Published 2 days ago
Expires 1 month from now
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No Deviation
Singapore