Equipment Validation Engineer (Perm, East, Office hours) - Opportunity to Make a Difference

Location: East

Working Hours: Mon – Fri: Office hours

Salary: Up to $4,500 per month + PB 

Job Description:

• 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).
• Perform matrices reporting such as safety incident report, submit safety matrices and monthly utilities usage for tracking and monitoring. 
• Assist in relevant license application / renewal from regulatory bodies pertaining to equipment use and laboratory operations. 
• Conducts periodic review, harmonisation of SOP for fitness-of-use, optimisation and compliance to appropriate regulations for equipment systems. 
• Attends monthly Environment, Health, Safety and Sustainability calls with manager. 
• 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.

Requirements:

• Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field
• 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.
• Understand concepts and rationale, and execute System Commissioning, Qualification and Validation for systems as per requirements stated in ISPE GAMP 5 and USP <1058> document is preferential.
• Only shortlisted candidates will be notified.