System Analyst

ANTER RECRUITMENT PTE. LTD.; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

ANTER RECRUITMENT PTE. LTD. is seeking an experienced Automation Validation Engineer to support GMP-compliant systems in our pharmaceutical client environment in Singapore.

You will prepare and execute CSV deliverables, and lead FAT/SAT and IQ/OQ testing across Siemens, Schneider, Allen Bradley platforms. The role requires 5–9 years in automation validation within GMP settings, strong knowledge of GAMP 5 and 21 CFR Part 11, and the ability to coordinate with cross‑functional teams to ensure

Qualifications

• Diploma/Degree in Automation, Electrical, Instrumentation or related engineering.
• 5–9 years of experience in automation and computer system validation in GMP pharma/biotech.
• Strong knowledge of GAMP 5 and 21 CFR Part 11.

Responsibilities

• Prepare and execute CSV deliverables (SLIA, DIRA, DSA, PURS, SRA, FS, DS, SOPs).
• Create FAT, SAT, IQ/OQ, H/SIOQ, and SIOQ protocols and summary reports.
• Lead system commissioning, FAT, and SAT activities.
• Coordinate with cross‑functional manufacturing and process teams for requirements and docs.
• Manage Project Change Management documentation and processes.
• Support OT system impact assessments on System/Component/Data Integrity/Data Security.
• Configure PLCs and DCS communications (Profinet, Modbus, CAN Bus).
• Support 21 CFR Part 11 e-record/e-signature compliance (alarms, audit, batch reporting).
• Work across Siemens, Schneider, and Allen Bradley platforms with DeltaV integration.
• Support validation and control of GMP-critical systems (CIP/SIP, autoclaves, WFI, HVAC, BMS/EMS).

Skills

GAMP 5 knowledge

21 CFR Part 11

PLC/SCADA knowledge

Siemens S7-1200/1500

TIA Portal

WinCC

DeltaV DCS integration

Kneat electronic validation

ISA-88 batch control

Cross-functional coordination

Education

Automation/Electrical/Instrumentation degree

Tools

Kneat

DeltaV DCS

S7-1200/1500

Job description

Key Responsibilities

• 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.

Requirements

• 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.