Senior GMP Calibration & Utility Engineering Lead

Ranbaxy (Malaysia) Sdn Bhd a SUN PHARMA company; Sungai Petani; On-site; MYR 120,000 - 180,000; Full time

Job summary

Sun Pharmaceutical Sdn Bhd is recruiting an experienced engineer to lead calibration systems, QMS, and utility operations for a GMP-compliant OSD facility. The role emphasizes regulatory compliance, equipment reliability, and audit readiness.

Responsibilities include managing calibration programs, handling deviations, CAPA, and change controls, plus overseeing HVAC and utility systems to maintain 99% uptime. Collaboration with QA, Production, and vendors is essential.

Qualifications

• Bachelor's degree in Mechanical, Electrical, or Instrumentation Engineering.
• 6–8 years of experience in pharmaceutical or medical device manufacturing.
• Experience supporting regulatory audits and maintaining GMP-compliant engineering operations.
• Strong knowledge of cGMP, regulatory compliance, HVAC and utility systems, calibration and validation, project management, and troubleshooting.
• Certification in QMS, project management, or related disciplines is an advantage.

Responsibilities

• Manage the GMP calibration programme for critical instruments, ensuring traceability to NABL or ISO 17025 standards and 100% compliance.
• Handle out-of-tolerance events, deviations, CAPA, and calibration records in accordance with written procedures.
• Monitor Engineering QMS activities, including change controls, deviations, CAPA, risk assessments, SOPs, and engineering documentation.
• Ensure compliance with cGMP, data integrity principles, and ALCOA+ requirements.
• Support regulatory, internal, and quality audits, including NPRA and CQA audits, and ensure timely closure of observations.
• Oversee HVAC, purified water systems, boilers, chillers, compressors, and other utility operations.
• Maintain cleanroom conditions, including temperature, relative humidity, and differential pressure, while achieving utility uptime of at least 99%.
• Implement preventive and predictive maintenance programmes and optimise energy usage and operating costs.
• Execute equipment installation, commissioning, and qualification activities, including DQ, IQ, OQ, and PQ.
• Coordinate project activities with QA, Production, vendors, and other stakeholders to deliver projects on schedule, within budget, and in compliance with applicable requirements.
• Support maintenance and lifecycle management for OSD equipment, including granulation, compression, coating, and packing systems.
• Ensure equipment qualification compliance, audit readiness, EHS compliance, and adherence to statutory requirements.

Skills

GMP compliance

Calibration management

QMS

Regulatory audits

CAPA

Education

Bachelor's degree in Mechanical, Electrical, or Instrumentation Engineering

Job description

Sun Pharmaceutical Sdn Bhd is recruiting an experienced engineer to lead calibration systems, QMS, and utility operations for a GMP-compliant OSD facility. The role emphasizes regulatory compliance, equipment reliability, and audit readiness.

Responsibilities include managing calibration programs, handling deviations, CAPA, and change controls, plus overseeing HVAC and utility systems to maintain 99% uptime. Collaboration with QA, Production, and vendors is essential.