Manager/Assistant Manager- Laboratory Operations Support (Mechanical background)

B Braun; Bayan Lepas; On-site; MYR 80,000 - 110,000; Full time

Job summary

A leading medical technology company located in Penang is seeking a Manager/Assistant Manager for Laboratory Operations Support. The ideal candidate will manage day-to-day lab activities, implement strategies to enhance operations, and ensure compliance with ISO and FDA standards. A strong technical background and experience in lab equipment management are essential. The role involves leading projects and fostering relationships with suppliers to maintain high service standards.

Qualifications

• Hands-on experience managing day-to-day lab test equipment, calibration, maintenance, and validation.
• Experience with ISO 13485, ISO 17025, GLP, GMP, or CLIA standards.

Responsibilities

• Implement organization’s strategy and manage laboratory operations.
• Lead complex projects and ensure compliance with specifications and standards.
• Manage relationships with suppliers to maintain service standards.

Skills

Technical guidance on lab instruments

Troubleshooting testing equipment

Problem-solving skills

Health, Safety & Environmental compliance knowledge

Education

Bachelor Degree in technical field

Job description

Manager/Assistant Manager- Laboratory Operations Support (Mechanical background)

Implement the organization’s strategy by managing activities in order to solve problems; improve or generate new operational or equipment systems; and install and commission new or replacement processes.

Manage the day‑to‑day activities of a group of executives, engineers and technicians, whose activities may include defining detailed maintenance methodology, calibration activities; setting‑up laboratory test equipment; SAP PM data; management laboratory equipment and common system to minimize laboratory downtime and interruptions.

Lead complex, controversial, or significant projects; evaluate findings; and prepare detailed reports with recommendations and conclusions, to achieve the organization goals and objectives.

Estimate the costs, resources, and time required to implement the organization’s annual goals and monitor the performance of projects to ensure targets are met.

Select and manage ongoing relationships with suppliers and vendors to ensure the organization receives satisfactory standards of service.

Introduce and develop the integration of new technology into the current lab processes to increase productivity, cost‑effectiveness, quality of work and enhance the capability of the team.

Lead the establishment of objectives, policies, standards and strategies in operational support best practices. Support in the development, modification, verification and validation of test method.

Hold the authority in approval of Test Report, IMS document, Quality Reports (CAPA, NCIR), Document Template, Validation Plan and Report, IMTE RA report, obsolete test equipment and jigs.

Have the authority and resources to implement, maintain and improve the management system, identify deviations from the management system or from the procedures for performing laboratory activities, initiate actions to prevent or minimize deviations, report to laboratory management on the performance of the management system and any need for improvement, and ensure the effectiveness of laboratory activities.

Ensure laboratory operation and projects are compliance to specification and relevant standard regulations, as well as ISO/IEC 17025, ISO 13485 and FDA quality system requirements.

What you will bring to the team:

Bachelor Degree in technical with hands‑on experience managing day‑to‑day lab test equipment, calibration, maintenance, and validation.

Providing technical guidance on lab instruments, methods, and procedures in physical testing and supervising lab technicians or support staff. Managing service contracts, negotiating with suppliers, or services provider.

Possess good technical knowledge in maintaining / troubleshoot testing equipment.

Good troubleshooting and problem‑solving skills

Health, Safety & Environmental (HSE) Compliance knowledge. Experience with ISO 13485, ISO 17025, GLP, GMP, or CLIA standards will be desired.

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.