The candidate is responsible for the validation of automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus and also have thermal mapping experience. In this role, the engineer has to work in accordance with the company’s policies and procedures to ensure validation is performed in accordance with quality requirements and regulations.
Responsibilities:
- Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols.
- Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols.
- Perform troubleshooting during test execution.
- Responsible for execution of thermal mapping activities.
- Write execution related deviations and change requests.
- Any other task as assigned by Supervisor/Manager.
Requirements:
- Diploma / Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls.
- Min. 3 years of experiences in CSV preferably in biotech facility.
- Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP)
- Familiar with Health Authorities standards (e.g., FDA CFR and EU)
- Knowledge of thermal mapping validation and usage of data logger is a plus.
- Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams
- Must be team player, curious with strong analytical and organizational skills
Contract length: 12 months. Option to extend/convert subject to performance review.
