Job Description

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.
DUTIES AND RESPONSIBILITIES * 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.

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.

About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Skills Required