Validation Engineer - Lab Devices (GMP)
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 a, 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.
- 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.
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.
- Provide support to manager and QA department during regulatory and internal/client audits.
- 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.
- Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field.
- Minimum 1 years of relevant experience in an ISO17025 / GMP environment is preferred.
- Min 1 to 2 years of experience in validation
Office Hours Monday to Friday
$3.2K to $4K
Interested candidates, please forward your resume to [Click Here to Email Your Resume]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
Recruit Express Pte Ltd