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A clinical-stage biotechnology company in Singapore seeks an Engineering Specialist to manage and maintain GMP-related equipment and facilities. The ideal candidate will have a bachelor's degree in engineering and at least 2 years of experience in GMP cleanroom environments. This role offers significant career growth opportunities within a rapidly evolving business environment.
About SCG
SCG Cell Therapy Pte Ltd is a Singapore based clinical-stage biotechnology company focusing on the development of novel immunotherapies for patients with pathogenic infections and associated cancers.
WHAT WE'LL OFFER YOU:
Job Description:
The candidate shall be responsible for the maintenance, calibration, servicing and general upkeep of SCG Cell Therapy's production and QC facilities, as well as all associated equipment therein. He/she shall be the engineering subject matter expert in all facility and equipment related queries, and must be familiar with cleanroom operations and pharmaceutical or medical device production environments.
Core responsibilities
- To manage the maintenance and upkeep of GMP-related equipment and facilities, including routine and/or preventive maintenance, calibration, repair works and replenishment of facility related consumables
- To lead engineering feasibility studies and any commissioning or remodeling projects, where applicable
- To perform basic inspection, maintenance and/or servicing of facility equipment, as well as testing of safety equipment such as eye washes, showers, etc.
- To serve as an engineering subject matter expert during risk assessment and mitigation activities, providing technical support and guidance.
- To provide a first response in the event of unplanned facility related excursions, including emergencies that may occur after office hours / weekends.
- To draft and update facility-related SOPs as needed
- Ensure that all relevant records and documentation are completed in a timely manner
- To oversee activities carried out by facility related vendors and to ensure compliance with GMP and other regulatory requirements.
- To work closely with internal stakeholders to understand and meet user requirements, ensuring optimal operation of labs while minimizing downtime.
Role requirements
- A bachelor's degree in civil, mechanical or electrical engineering
- At least 2 years of experience maintaining GMP cleanrooms or 5 years of experience with similar controlled environment facilities
- Familiarity with PIC/S GMP requirements is a plus
- Hands-on experience working with chilled water ACMV systems is a plus
- Prior HSE experience is a plus