Cleanroom Technician

High5; Johor; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Clean Room Technician to ensure compliance with Good Manufacturing Practices (GMP) and maintain cleanroom integrity. The role involves preventive maintenance, vendor coordination, and rigorous documentation practices. Ideal candidates will hold a relevant degree and possess 2-3 years of related experience, demonstrating strong technical skills and attention to detail in a controlled environment.

Qualifications

• 2-3 years of experience in cleanroom operations preferred.
• Familiarity with cleanroom protocols and cleanliness standards.
• Fluency in English required.

Responsibilities

• Maintain cleanroom integrity and compliance with GMP.
• Conduct preventive maintenance on clean utilities equipment.
• Monitor and troubleshoot clean utilities equipment continuously.

Skills

Attention to Detail

Problem-Solving

Communication Skills

Education

Bachelor's degree in Biotechnology, Biochemistry, or a related field

Tools

SAP

Job description

Job Title: Clean Room Technician

Industry: Pharmaceuticals / Biotechnology / Medical Devices

Position Type: Full-time

About the Role

We are seeking a diligent and detail-oriented Clean Room Technician to join our team. This role is pivotal in maintaining the integrity of our controlled environments, ensuring compliance with Good Manufacturing Practices (GMP), and supporting the seamless operation of our clean utilities and equipment.

Key Responsibilities

Training & Documentation

• Vendor Coordination: Liaise with external vendors for site services and repairs.
• EHS Collaboration: Work with Environment, Health, and Safety (EHS) teams for documentation, permit registrations, and Lockout/Tagout (LOTO) procedures.
• Training Oversight: Coordinate and ensure training is imparted to external vendors.
• Record Keeping: Attend, record, and conduct all required trainings as per the training matrix/schedule.
• Documentation Compliance: Fill log sheets, checklists, and planners as per Standard Operating Procedures (SOPs).
• Permit Management: Issue work permits and gate passes as necessary

Preventive Maintenance (PM)

• Maintenance Execution: Carry out planned preventive maintenance on clean utilities equipment to achieve maximum plant availability with a target of zero unplanned downtime.
• Communication: Raise communication memos for preventive maintenance activities.
• Maintenance Records: Respond to, carry out, and record equipment maintenance activities effectively and efficiently.

Operations & Equipment Monitoring

• Continuous Monitoring: Monitor and troubleshoot clean utilities equipment continuously.
• Spare Parts Management: Maintain availability of spare parts for all equipment at all times to ensure no downtime due to non-availability.
• Proactive Maintenance: Observe and rectify equipment/machine conditions, detecting unusual conditions proactively.
• Manufacturer Compliance: Ensure all equipment operates and is maintained as per manufacturer's recommendations.
• Process Familiarization: Familiarize with the manufacturing process and related equipment.
• Daily Reporting: Provide daily reports of activities and update any issues at work to the superior.
• SAP Utilization: Learn and practice SAP for activities such as raising, addressing, and closing notifications/work orders.
• Project Participation: Participate in project activities on process optimization, facility upgrades, or objectives.
• Objective Setting: Propose objectives and targets for the work area and comply with set timelines.

Qualification & Validation Support

• Commissioning Support: Support commissioning/validation activities, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Requalification (RQ).
• Documentation Generation: Generate various documents, procedures, protocols, and reports as and when required.

Training & Compliance

• GxP Training: Gain knowledge on subjects relevant to the job profile, such as Basics of cGMP, Good Documentation Practices (GDP), Data Integrity, Good Laboratory Practices (GLP), Microbiology, or any other GxP training, as applicable.
• Mandatory Training: Employees involved in GMP activities should undergo mandatory cGMP training once a year.
• Microbiology Training: All employees working in GxP environments should undergo mandatory basic microbiology training.
• Documentation Compliance: Ensure all documentation is accurate, timely, legible, complete, and permanent, adhering to the ALCOA principle.

Qualifications & Skills

• Educational Background: Bachelor's degree in Biotechnology, Biochemistry, or a related field.
• Experience: 2-3 years of experience in cleanroom operations, preferably in the pharmaceutical or medical device industry.
• Technical Skills: Familiarity with cleanroom protocols, gowning procedures, and cleanliness standards.
• Knowledge: Understanding of clean utilities equipment and their maintenance.
• Software Proficiency: Experience with SAP or similar Enterprise Resource Planning (ERP) systems is a plus.
• Communication Skills: Strong verbal and written communication skills.
• Attention to Detail: Meticulous in documentation and adherence to protocols.
• Problem-Solving: Ability to troubleshoot and resolve equipment and process issues efficiently.

Additional Information

• Work Environment: The role requires working in a controlled cleanroom environment, adhering to strict hygiene and safety protocols.
• Physical Requirements: Ability to stand for extended periods, lift moderate weights, and perform repetitive tasks.
• Language Proficiency: Fluency in English is required; knowledge of additional languages is a plus.