Facilities Senior Engineer

St. Jude Medical; Bayan Lepas; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical technology firm in Penang is seeking a Facilities Engineer to oversee critical facility systems, ensuring compliance with GMP and ISO standards. The role requires a Bachelor's degree in engineering and 5-8 years of experience in facilities engineering, preferably in the medical device industry. Key responsibilities include managing facility-related projects, maintaining systems, and ensuring regulatory compliance.

Qualifications

• 5–8 years of experience in facilities engineering, preferable in medical device or pharmaceutical manufacturing.
• Strong understanding of GMP, ISO 13485, and FDA 21 CFR Part 820.
• Experience with validated systems and facility qualification protocols (IQ/OQ/PQ).

Responsibilities

• Oversee facility systems including HVAC, water systems, and cleanroom environments.
• Lead facility-related capital projects including expansions and equipment installations.
• Ensure compliance with local regulations and FDA requirements.

Skills

Problem-solving

Communication

Leadership

Project Management

Education

Bachelor’s Degree in Mechanical, Electrical, or Facilities Engineering

Tools

AutoCAD

CMMS

Project Management Tools

Job description

Overview

Oversee and maintain critical facility systems including HVAC, purified water systems, compressed air, and cleanroom environments. Ensure validated systems remain in a state of control and operate within defined parameters. Lead preventive and corrective maintenance programs aligned with GMP and ISO 13485 standards.

Project Management

Lead facility-related capital projects including expansions, equipment installations, and infrastructure upgrades. Develop and manage project scopes, budgets, timelines, and risk assessments.

Compliance & Quality

Ensure facilities comply with local regulations, FDA requirements, and ISO 13485 standards. Support internal and external audits, including FDA and Notified Body inspections. Maintain documentation for facility validation, change control, and CAPA processes. Monitor and maintain cleanroom conditions including temperature, humidity, pressure differentials, and particle counts. Coordinate environmental monitoring programs and support contamination control strategies. Manage service contracts and performance of external vendors and contractors. Ensure work performed meets quality, safety, and regulatory standards.

Sustainability & Energy Management

Identify and implement energy efficiency and sustainability initiatives. Monitor utility usage and recommend cost-effective improvements.

We Are Looking For

Bachelor’s Degree in Mechanical, Electrical, or Facilities Engineering or related field. Minimum 5–8 years of experience in facilities engineering, preferably in medical device or pharmaceutical manufacturing. Strong understanding of GMP, ISO 13485, FDA 21 CFR Part 820, and cleanroom operations. Experience with validated systems and facility qualification protocols (IQ/OQ/PQ). Proficient in AutoCAD, CMMS, and project management tools. Excellent problem-solving, communication, and leadership skills. Professional certifications (e.g., PMP, Certified Biomedical Auditor, Certified Energy Manager). Experience in Class III medical device manufacturing or aseptic environments. Familiarity with environmental monitoring systems and Building Management Systems (BMS).