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Execute the full CSV lifecycle for PLC and SCADA systems, including risk assessments and qualification of hardware and software. Ensure compliance with GMP data-integrity requirements and support system integration with MES and ERP platforms.
Requires a Bachelor's degree in Engineering or Computer Science and at least 5 years of CSV experience in a GMP-regulated environment. Proficiency in PLC/SCADA platforms and knowledge of GAMP 5 and FDA regulations are essential.
AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking a PLC/SCADA CSV Engineer to validate and qualify automation hardware, software, and system interfaces in compliance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and GMP data-integrity requirements.
Preferred / Advantageous
Delivering innovation through technology for Life Science manufacturing!
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization, helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation, Manufacturing Execution Systems (MES), OT Networking and Digital Technologies.
Offices: Singapore, SG · Cork, IE · Pune, IN · Dover, DE, US
