Kerja Sepenuh Masa, Automation Engineer di Coalesce Management Consulting - Maukerja

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 and support CAPA, change control, periodic review and system lifecycle activities.
• Work closely with Engineering, Manufacturing, Quality Assurance, IT, vendors and system integrators.
• Support automation troubleshooting, system upgrades, modifications and commissioning activities.
• Maintain validated system status throughout the equipment and system lifecycle.

Requirements

• Relevant experience supporting automation or computer system validation within pharmaceutical, biotechnology or other regulated manufacturing environments.
• Strong hands-on knowledge of Siemens PCS 7, including system architecture, configuration, testing and troubleshooting.
• Experience with DCS, PLC, SCADA, HMI, batch control systems or process automation.
• Familiarity with CSV documentation and the execution of IQ/OQ protocols.