Laboratory Operations Lead - Onsite, Impact & Innovation

B. Braun; Bayan Lepas; On-site; MYR 60,000 - 88,000; Full time

Benefits offered by this job

Employee Incentive Scheme

Meal Subsidy

Onsite fitness facilities

Job summary

B. Braun Group in Bayan Lepas, Penang, Malaysia invites a Manager - Laboratory Operations Support to lead laboratory operations, equipment maintenance and process improvements.

You will supervise engineers and technicians, drive calibration, validation and method verification, and ensure GMP/QMS compliance with ISO/IEC 17025 and ISO 13485 standards. Join a global healthcare leader driving innovation and quality.

Qualifications

• 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.
• Health, Safety & Environmental (HSE) compliance knowledge; ISO 13485, ISO 17025, GLP, GMP, or CLIA standards desired.
• Experience introducing and developing the integration of new technology into lab processes to increase productivity, cost effectiveness, and quality.

Responsibilities

• Implement the organization’s strategy by managing activities to solve problems; improve or generate new operating or equipment systems; install and commission new or replacement processes.
• Lead day-to-day activities of a group of executives, engineers and technicians; manage maintenance and calibration activities; set up lab test equipment; manage SAP PM data.
• Lead complex projects; evaluate findings; prepare detailed reports with recommendations and conclusions; estimate costs, resources, and time for annual goals; monitor project performance.
• Select and manage ongoing relationships with suppliers and vendors to ensure service standards; develop integration of new technology into current lab processes to increase productivity and quality.
• Lead the establishment of objectives, policies, standards and strategies in operational support best practices; approve Test Reports, IMS documents, Quality Reports (CAPA, NCIR), and Validation Plans.
• Ensure compliance to ISO/IEC 17025, ISO 13485 and FDA quality system requirements; manage deviations and improvements in the laboratory management system.

Skills

Technical guidance

Troubleshooting

Problem-solving

HSE knowledge

Leadership

Education

Bachelor Degree in technical field

Tools

Lab equipment maintenance tools

Calibration equipment

SAP PM data

Job description

B. Braun Group in Bayan Lepas, Penang, Malaysia invites a Manager - Laboratory Operations Support to lead laboratory operations, equipment maintenance and process improvements.

You will supervise engineers and technicians, drive calibration, validation and method verification, and ensure GMP/QMS compliance with ISO/IEC 17025 and ISO 13485 standards. Join a global healthcare leader driving innovation and quality.