Validation Engineer (Office Hours/Immediate)
1) Equipment, Facility, Safety and Cost Management / Support
- Update or monitor the Master Schedule and Equipment Control Database for equipment – related activities to ensure that equipment activities are performed according to SOP.
- Schedule, coordinate and supervise periodic maintenance, repairs and calibration of equipment, instrumentation, and critical utilities at Charles River Singapore facility, which may include liaising external vendors.
- Schedule and oversee internal IOPQ activities and verification activities, where needed, for new equipment and instrumentation in compliance to ICH, CGMP, and ISO/IEC 17025 guidelines.
- Manage facility maintenance activities including performing risk assessments and coordinating with external vendors e.g. pest control programmes, Continuous Monitoring System (CMS), biohazard & chemical waste management programmes, etc.
- Perform and / or review risk assessment where applicable
- Manage and trend safety incidents for the site.
- Updates safety matrices where applicable.
- Submits safety matrices and monthly utilities bills to global EHS organisation.
- Assist in relevant license application / renewal from regulatory bodies pertaining to equipment use and laboratory operations.
- Document Management
- Conduct periodic amendment, reviews or harmonisation of SOPs for relevance, fitness-of-use, optimisation and compliance to appropriate regulations for equipment-, and instrumentation- matters.
- Responsible for drafting new SOPs pertaining to equipment use and facility operations.
- Ensure completion, maintenance and archival of completed qualification protocols and/or service reports
- Maintains documentation on new/existing laboratory equipment, repairs and failures.
- Manage timeline and oversee implementation of projects as required by the site to align to the requirements and objectives of the organisation.
- Support procurement activities within area of responsibility.
- Coordinate, conducts meeting and negotiate with vendors via period contracts or maintenance contracts to obtain competitive pricing for the subcontracted area of work.
- Assist and support manager in budgeting and planning for the department.
- Attends monthly Sustainability and Environment, Health and Safety (EHS) meetings, or other relevant corporate calls with manager.
- Conducting of training for new staff on matters related to Equipment, Facility and Safety processes
- Mentoring of junior EFTS members or contract staff, where applicable.
2) IT Support
- Coordinate with IT personnel in-charge, where applicable for Equipment Systems, workstations and servers troubleshooting.
- Provide support to manager and QA department during regulatory and internal/client audits.
- SME for Equipment systems, EndoSafe, Axcess and/or AccuGENX-ID systems (software and hardware), (where applicable).
- Prepare or review change management and other appropriate quality assurance documents in the event of critical / major change in equipment, instrumentation and facilities.
- Maintain or review appropriate records and documentation of activities to facilitate continuous compliance to ISO/IEC 17025, CGMP, PIC/S, Company local and global SOPs and data integrity principles.
- Assist manager and QA department in the event of an investigation and the area of responsibility.
4) Continuously seek improvement in areas of responsibility.
5) Adheres to Company Policies and Procedures.
6) Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.
- Minimum Degree in Engineering, Biomedical Sciences or any related field.
- Minimum 1 year of relevant experience in an ISO17025 / GMP environment will be an advantage but not necessary
- Able to start work immediately
Interested applicants please send your resume to [Click Here to Email Your Resume]
Ho Yun Xin Claire (R2091773)
RECRUIT EXPRESS PTE LTD (99C4599)
Recruit Express Pte Ltd