Senior Specialist-automation

1 week ago

Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

**1.**Key Responsibilities**:

- The Automation Engineer is responsible for designing, implementing, troubleshooting, and maintaining automation systems supporting the pharmaceutical tablet manufacturing process.
- This includes working with PLCs, SCADA, DCS, EMS, BMS, HMI systems, and ensuring compliance with cGMP and regulatory standards (e.g., FDA 21 CFR Part 11, PIC/S).
- Support and maintain automation systems for tablet compression, granulation, coating, blending, and packaging processes.
- Manage control systems (e.g., Siemens, Allen Bradley, DeltaV) for process equipment (e.g., FBD, RMG, Tablet Press, Coater).
- Ensure system compliance with data integrity and audit trail requirements.
- Troubleshoot and resolve automation issues, minimize downtime.
- Perform routine system backups, patch management, and cybersecurity controls.
- Lead or support automation upgrades or integration of new equipment.
- To be a part of MES integration for batch execution software. Interfaces with MES (Manufacturing Execution System), ERP (SAP).

**2. Compliance & Certification**:

- Ensure compliance with Singapore’s HSA, EHS, and internal SOPs. Develop and maintain automation documentation including URS, FDS, SDS, IQ/OQ protocols.
- Execute automation change controls and support qualification/validation activities.
- Collaborate with cross-functional teams: QA, Manufacturing, Engineering, IT, Validation.
- Ensures **data integrity**(audit trails, user access control) per **21 CFR Part 11**.
- Secure electronic batch records and event logs.

**3. Projects & Upgrades**:

- Support modification, and validation projects involving software systems.
- Integration with BMS/EMS for facility safety and environment monitoring.
- Coordinate with contractors and ensure commissioning is done per regulatory and safety standards.

**Requirements**:

- **Education**:Degree in Electrical, Electronics, Automation or related field.
- **Experience**:3 -7 years of experience in automation.
- Experience with BMS/EMS is a plus.
- Able to read P&IDs, electrical diagrams, and technical drawings.
- Good problem-solving and documentation skills.

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