Assistant Director, Engineering

**Assistant Director, Engineering & Environment, Health, and Safety**

**Overview**

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.

The Business Entities under CRIS include:

- Singapore Clinical Research Institute (SCRI)
- National Health Innovation Centre (NHIC)
- Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
- Precision Health Research, Singapore (PRECISE)
- Singapore Translational Cancer Consortium (STCC)
- Cardiovascular Disease National Collaborative Enterprise (CADENCE)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you

**ACTRIS**

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life-threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular-based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value-added services such as workforce training, regulatory facilitation and ancillary material standardization, pertaining to delivery of cellular therapy to patients.

**What you will be working on**

The facilities & EHS Assistant Director is responsible for ensuring that a manufacturing facility for cell and gene therapy products meets the regulatory & WSH (workplace safety and health) requirements. The director is overseeing and managing all aspects of facility operations, maintenance, and compliance with GMP guideline. The facilities director works closely with cross-functional teams, contractors, and vendors to maintain a compliant, safe, and efficient facility.

Major Duties Or Responsibilities

Manage Facility Engineering Strategy & Planning and Compliance:

- Ensuring that the facility is in compliance with GMP regulations. This includes developing and implementing procedures and processes, maintaining accurate and up to date records and documentation, conducting regular audits to ensure compliance, reporting incidences and preparing reports and data as required by management or to regulatory authorities.
- Lead / oversee equipment
- and system-related investigations, CAPAs, deviations and change controls, review and approve records.
- Overseeing routine maintenance for the facility and lab & production equipment. Ensuring proper & timely maintenance, calibration and operation of all equipment, facility M&E, safety and security equipment such as HVAC, CCTVs, access control, etc. Ensuring all facilities systems and equipment are functioning properly.
- Managing contractors and stakeholders to ensure regulatory & safety requirements, operating standards, established protocols and the service level requirements of integrated facilities management are met.
- Partner with key stakeholders to meet user requirements and optimal functioning of all laboratory & production and building spaces.
- Responsible for managing the Building Management System, Environment Monitoring System and the facility SMS alarm.
- Develop solutions to complex issues and Facilities / Engineering initiatives with cross-functional team leaders, following cGMP regulations and internal procedures in accordance with applicable regulatory standards

Maintain workplace safety & health (WSH):

- To develop and implement WSH management system and risk management plan, conducting regular safety inspections, addressing safety concerns, and coordinating with security personnel to prevent unauthorized access or other security threats.
- Evaluate WSH non-compliance, unsafe work conditions and practices to identify WSH performance gaps.
- Manage risk in the workplace, recommend, implement actions, and review effectiveness of measures to improve WSH performance and control risks.
- Conduct incidents investigations and make recommendations to address root cause of incidents.
- Provide advice to Management with respect to changes in the Acts, Regulations, Codes of Practice and Standards, and make recommendations on any aspects of workplace safety & health and environment protection matters.

Managing Any other operational related duties/projects as assigned

**What we are looking for**
- EDUCATION, TRAINING

Degree holder in a Sciences Related, Engineering, Occupational Safety and Health or related fields
- EXPERIENCE
- At least 15 years relevant working experience in managing Good Manufacturing Practice (GMP) f