Clean Utilities Engineer

RP International; Johor; On-site; MYR 100,000 - 150,000; Full time

Job summary

An exciting opportunity exists for a Clean Utilities Engineer in Malaysia. This role involves overseeing clean utility systems with responsibilities in equipment maintenance, vendor coordination, and ensuring compliance with GMP standards in a leading pharmaceutical environment.

Qualifications

• Prior experience in a GMP-compliant facility.
• Solid understanding of clean utility systems.
• Familiarity with maintenance tracking systems.

Responsibilities

• Oversee preventive maintenance and vendor coordination.
• Ensure compliance with regulatory standards.
• Document daily activities and equipment conditions.

Skills

Analytical skills

Organizational skills

Communication

Tools

SAP

Job description

An exciting opportunity is available for a Clean Utilities Engineer to join a high-performing team within a leading pharmaceutical and biotechnology manufacturing environment in Malaysia. This contract position is ideal for a driven engineering professional seeking hands-on experience in a GMP-regulated facility.

Role Overview:

The successful candidate will be responsible for overseeing preventive maintenance, vendor coordination, equipment operation, and documentation related to clean utility systems. The role involves working cross-functionally to ensure systems remain fully operational, compliant, and efficient.

Key Responsibilities:

• Liaise with external service providers for equipment servicing and repairs, ensuring all safety documentation and access permits are managed in accordance with site protocols.
• Ensure vendors are trained as per the training matrix/schedule, and maintain accurate training records.
• Complete log sheets, checklists, and planners in alignment with standard operating procedures (SOPs).
• Execute scheduled maintenance activities on clean utility systems to minimize unplanned downtime and maximize availability.
• Raise internal communication memos to initiate maintenance tasks and document outcomes effectively.
• Perform equipment servicing with a focus on safety, compliance, and accuracy.
• Continuously monitor clean utility systems, troubleshoot issues, and proactively resolve abnormal conditions.
• Ensure spare parts are stocked adequately to avoid delays in maintenance or repairs.
• Maintain operational integrity in line with manufacturer specifications and regulatory standards.
• Document daily activities, observations, and equipment conditions in logbooks and digital systems (e.g., SAP).
• Support process optimization projects and contribute to facility enhancement initiatives.
• Propose and work towards operational targets within established timelines.
• Participate in commissioning and validation processes including FAT, SAT, DQ, IQ, OQ, PQ, and RQ.
• Draft and review protocols, reports, and procedural documents as needed.
• Adhere to Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulatory frameworks.
• Attend mandatory training in microbiology, data integrity, and other GxP-related areas annually.
• Uphold ALCOA principles to ensure documentation is accurate, legible, complete, timely, and permanent.
• Offer guidance and support to ensure site compliance with GDP and data integrity expectations.

Qualifications & Skills:

• Prior experience in a GMP-compliant facility, ideally in pharmaceutical or biotech industries.
• Solid understanding of clean utility systems, preventive maintenance, and equipment troubleshooting.
• Familiarity with SAP or similar enterprise systems for maintenance tracking is an advantage.
• Strong analytical, organizational, and communication abilities.

Interested applicants or referrals may be sent to [e-mail]