System Analyst

Summary

Validate and commission automation systems for pharmaceutical manufacturing, ensuring GMP compliance and 21 CFR Part 11 e-records standards.

Prepare and execute Computer System Validation (CSV) deliverables, including SLIA, DIRA, DSA, PURS, SRA, FS, DS, and SOPs.
Prepare and execute FAT, SAT, IQ/OQ, H/SIOQ and SIOQ protocols, and associated Summary Reports.
Lead system commissioning, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT).
Coordinate with cross-functional manufacturing and process teams to gather system requirements and manage project documentation.
Manage Project Change Management (PCM) documentation and processes.
Support OT system impact assessments across System Level, Component Level, Data Integrity, and Data Security.
Configure and maintain communication between PLCs and DCS platforms (e.g. Profinet, Modbus, CAN Bus).
Support 21 CFR Part 11 e-records/e-signature compliance, including alarm, audit, and batch reporting.
Work across multi-platform automation systems including Siemens, Schneider, and Allen Bradley, with DeltaV DCS integration.
Support validation and control of GMP-critical systems such as CIP/SIP, autoclaves, WFI, HVAC, and BMS/EMS.

Diploma/Degree in Automation, Electrical, Instrumentation, or a related Engineering discipline.
At least 5–9 years of relevant experience in automation and computer system validation within GMP-regulated pharmaceutical or biotech environments.
Strong working knowledge of GAMP 5 and 21 CFR Part 11 requirements.
Hands-on experience with PLC/SCADA platforms such as Siemens (S7-1200/1500, TIA Portal, WinCC), Schneider EcoStruxure, and/or Allen Bradley.
Familiarity with DeltaV DCS integration is an advantage.
Experience with electronic validation platforms (e.g. Kneat) is an advantage.
Understanding of ISA-88 (S88) batch control systems is a plus.
Good communication and cross-functional coordination skills; able to work independently and lead documentation efforts.