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Clean Room Manufacturing Lead

Penerangan Pekerjaan - Clean Room Manufacturing Lead

Description

The Cleanroom Manufacturing Team Lead is responsible for leading and coordinating daily manufacturing operations within the cleanroom environment to ensure the safe, efficient, and compliant production of high-quality products. The role supervises production operators, ensures adherence to cleanroom protocols, quality standards, and production schedules, while driving continuous improvement, operational excellence, and team development.

Responsibilities:

  • Lead and supervise daily cleanroom manufacturing operations to achieve production, quality, safety, and delivery targets.
  • Plan and allocate manpower based on production schedules and operational priorities.
  • Monitor production output, cycle time, yield, and line performance, implementing corrective actions to minimize downtime.
  • Coordinate shift handovers and conduct daily production meetings to communicate priorities, quality alerts, and safety updates.
  • Escalate production issues, equipment failures, material shortages, and resource constraints to the Production Supervisor.
  • Supervise, coach, and develop Cleanroom Manufacturing Technicians and Operators to ensure high performance and compliance.
  • Conduct on-the-job training and ensure employees are qualified and certified for assigned manufacturing processes.
  • Monitor employee attendance, discipline, and productivity while providing regular coaching and performance feedback.
  • Support onboarding and cross-training initiatives to enhance workforce flexibility and succession planning.
  • Foster a culture of teamwork, accountability, and continuous improvement.
  • Ensure strict compliance with cleanroom gowning procedures, contamination control practices, and cleanroom protocols.
  • Monitor environmental discipline and ensure adherence to cleanliness standards to prevent product contamination.
  • Ensure operators follow approved Standard Operating Procedures (SOPs), work instructions, and Good Manufacturing Practices (GMP), where applicable.
  • Support cleanroom audits and maintain audit readiness at all times.
  • Ensure products are manufactured in accordance with engineering drawings, work instructions, quality standards, and customer specifications.
  • Verify completion of first-piece approvals, in-process inspections, and final inspections.
  • Investigate quality issues, support root cause analysis, and implement corrective and preventive actions.
  • Drive initiatives to improve yield, reduce defects, and eliminate rework and scrap.
  • Ensure compliance with ISO 9001, ISO 13485 (where applicable), and internal Quality Management System requirements.


Requirements:

  • Minimum Diploma in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related technical discipline.
  • Supervisory or leadership training is an added advantage.
  • Minimum 3–5 years of manufacturing experience in a cleanroom production environment.
  • Minimum 1–2 years of experience in a supervisory or team leadership role.
  • Experience in medical device, semiconductor, precision manufacturing, electronics, or similar cleanroom operations is preferred.
  • Strong understanding of cleanroom manufacturing practices and contamination control.
  • Knowledge of cleanroom classifications, gowning procedures, and environmental controls.
  • Ability to read and interpret engineering drawings, work instructions, and manufacturing documentation.
  • Knowledge of Lean Manufacturing, 5S, problem-solving tools, and continuous improvement methodologies.
  • Familiarity with quality management systems such as ISO 9001 and ISO 13485 (where applicable).
  • Strong leadership, coaching, communication, and interpersonal skills.
  • Good analytical and decision-making abilities.
  • Basic computer proficiency in Microsoft Office and Manufacturing Execution Systems (MES) or ERP systems.


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