For nearly 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

POSITION SUMMARY

This role’s focus is on the planning, coordinating and resourcing routine equipment and/or facility maintenance activities and projects on-site. He/She ensures the qualification and validation of equipment, facilities, utilities, and processes are carried out in accordance with applicable GMP, GLP and/or ISO 17025 guidelines.

GENERAL REQUIREMENTS

Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.

• Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
• Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.
• Performs all other related duties as assigned.

QUALIFICATIONS:

1. Education: Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field.

2. EXPERIENCE:

• Minimum 1 year of relevant experience working in an ISO17025 / GLP / GMP environment is preferred.
• Understanding of IT is expected, related to installation of software, interface of hardware and software and basic administrative controls of Windows (Such as adding user groups) is preferred.

• Update or monitor the Master Schedule and Equipment Control Database for equipment-related activities to ensure that they are performed according to SOP.
• Schedule, coordinate and supervise periodic maintenance, performed in-house or as arranged with external vendors for repair and calibration of equipment, and critical utilities at Charles River Singapore.
• Manage facility maintenance activities and coordinate with external vendors for facility needs and requirements (For example, Pest Control programmes, biohazard and chemical waste management programmes, etc).
• Maintain preventive maintenance contracts for equipment and facilities for the site and to ensure that contracts are kept in force.
• Manage the installation, maintenance, operation, repair and adjustments made to all equipment and Facilities e.g. (HVAC, pumps, boilers, air handling units, air compressors, etc.).
• Oversee daily operational activities in Facilities and Equipment Calibration. Ensure all reporting staff and \ or Contractors understand their roles and responsibilities and their tasks are performed in accordance with site procedures.
• Overall management of all external contractor services to include quotations/costs, risk assessments, method statements and work permits in advance of work being carried out.
• Perform matrices reporting such as safety incident report, submit safety matrices and monthly utilities usage for tracking and monitoring.
• Conducts periodic review, harmonisation of SOP for fitness-of-use, optimisation and compliance to appropriate regulations for equipment systems.
• Able to conduct training for various equipment systems being deployed in Charles River Singapore.
• Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, Company global SOPs and other data integrity principles for all activities.
• To work closely with all departments to ensure the operation of a validated environment according to existing QMS and/or other regulatory requirements.
• Performs all functions as tasked with high degree of accuracy and strict adherence to company’s quality requirements.
• Reviews aspects/areas for improvement within your own duties/responsibilities and make recommendations to your line manager for your own or team improvements.
• Adheres to Company Policies and Procedures.
• Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.