Lab Operation Support Engineer/ Senior Lab Operation Support Engineer

Job Summary

To support the QA/RA Head of Department in the establishment, operation, and maintenance of the MY site laboratory.

The role is responsible for executing and coordinating laboratory testing activities, managing laboratory equipment and processes, and supporting technical evaluations across different stages of the product lifecycle. The position focuses on laboratory operation and test execution, aligned with corporate technical requirements, without ownership of product development, quality release, or validation decisions.

Qualifications & Experience:

• Minimum Bachelor Degree in Engineering or technicalwith hands-on experience managing day-to-day lab test equipment, calibration, maintenance, and validation.
• Minimum 2 years of relevant experience in a quality lab, preferably in a medical device, pharmaceutical, or biotech manufacturing environment.
• Knowledge of Health, Safety & Environmental (HSE) Compliance, good laboratory practices (GLP), ISO 13485, FDA 21 CFR Part 820, and GMP standards is added advantages.
• Poses good technical knowledge in handling / maintaining / troubleshooting laboratory instruments and interpreting technical data.
• Experience in introducing and developing the integration of new technology into lab processes to increase productivity, cost effectiveness, quality of work and enhance the capability of the team is an advantage
• Familiarity with machine measurement systems, such as vision cameras and sensors, as well as function testing for leaks and blockages and problem-solving skills are beneficial.
• Experience in project management, failure analysis, and Measurement System Analysis (MSA) are preferred.

Key Responsibilities:

• Support the setup, operation, and continuous improvement of site laboratory facilities, equipment, and workflows.
• Coordinate installation, commissioning, routine maintenance, calibration coordination, and troubleshooting of laboratory instruments to ensure readiness and minimise downtime.
• Maintain laboratory equipment records, status logs, and maintenance documentation.
• Execute laboratory tests in accordance with approved methods, work instructions, and protocols.
• Compile laboratory test data into clear and accurate reports for internal technical evaluation purposes.
• Support technical testing requests related to development, investigation, validation, or post-market activities, as defined by approved protocols.
• Support the development, adaptation, and documentation of site-level laboratory test methods where no existing corporate method is available or where site-specific execution is required.
• Ensure locally developed methods are technically justified, documented, and aligned with applicable corporate technical requirements.
• Support method verification or qualification activities for site-developed methods, where required.
• Ensure site-developed methods do not replace or modify product-defining or specification-setting test methods without appropriate corporate alignment.
• Develop and maintain laboratory SOPs, work instructions, and operational documentation relevant to laboratory activities.
• Ensure proper control, filing, and traceability of laboratory records, including test reports, equipment logs, and technical data, in accordance with internal procedures.
• Liaise with Corporate Technical & Development teams to align on test methods, technical expectations, and data interpretation, in the absence of a local T&D function.
• Coordinate with external laboratories where specialised or outsourced testing is required.
• Ensure laboratory activities are conducted in alignment with internal procedures and applicable regulatory principles (e.g. ISO 13485, FDA QSR), without implying formal laboratory accreditation (e.g. ISO/IEC 17025).
• Support laboratory-related investigations by providing test data and technical input, as requested by the relevant function.
• Assist in stability studies and environmental monitoring, as required.
• Prepare and review environmental monitoring trend analysis report.
• Provide technical training and guidance on laboratory equipment, test methods, and procedures to laboratory personnel or new recruits, where applicable.
• Maintain awareness of assigned training requirements and ensure timely completion.
• Manage procurement and inventory of laboratory consumables, reagents, and related supplies.
• Provide backup support for laboratory activities and other assigned technical tasks, as required.
• Support any other duties within the role or task assigned from time to time.

Why join us:

• Be part of a growing medical device company with a new facility launching in the next year
• Excellent career advancement opportunities for high achievers
• Competitive salary package with medical and insurance coverage
• Enjoy a familial company atmosphere