Senior Manager – Engineering & Maintenance

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 120,000 - 150,000; Full time

Job summary

A leading biosimilars company in Malaysia seeks a Senior Manager – Engineering & Maintenance to oversee maintenance activities for process equipment, HVAC systems, and clean utilities. The ideal candidate will have at least 10 years of experience in pharmaceutical or biotech industries, strong technical knowledge, and leadership capabilities. This role involves strategic planning and compliance with regulatory standards.

Qualifications

• 10+ years of experience in pharmaceutical, biotech, or FMCG industry.
• Strong knowledge of GMP, HVAC, clean utilities, and process equipment.
• Experience in managing cross-functional teams and engineering projects.

Responsibilities

• Oversee maintenance of manufacturing and process equipment.
• Manage operations and maintenance of HVAC systems.
• Supervise maintenance of clean utilities for manufacturing operations.
• Lead a team of engineers and technicians ensuring compliance.

Skills

Technical expertise in equipment and utility systems

Leadership and team management

Problem-solving and decision-making

Project management

Regulatory compliance and documentation

Education

Bachelor’s or Master’s degree in Mechanical/Electrical Engineering

Tools

AutoCAD

MS Office tools

Job description

Senior Manager – Engineering & Maintenance

Biocon Biologics is a leading company in the biosimilars field with a focus on affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company committed to bringing high-quality, affordable biosimilars to patients worldwide.

Required Experience - 10+ Years.

The Senior Manager – Engineering & Maintenance is responsible for leading and managing the maintenance activities of process equipment, HVAC systems, and clean utility systems to ensure optimal performance, compliance with regulatory standards, and uninterrupted operations. This role involves strategic planning, team leadership, and cross-functional collaboration to support manufacturing and facility operations.

Key Responsibilities:

1. Process Equipment Maintenance
   • Oversee preventive, predictive, and corrective maintenance of all manufacturing and process equipment.
   • Ensure equipment reliability and availability to meet production targets.
   • Lead root cause analysis and implement corrective actions for equipment failures.
   • Maintain equipment history and documentation.
   • Coordinate with production and quality teams for equipment qualification and validation.
2. HVAC System Management
   • Manage operations and maintenance of HVAC systems including AHUs, chillers, ducting, and BMS.
   • Ensure compliance with cleanroom environmental conditions (temperature, humidity, pressure differentials).
   • Monitor HVAC performance and implement energy-efficient practices.
   • Lead HVAC system upgrades and modifications as per GMP and regulatory requirements.
3. Clean Utility Systems
   • Supervise maintenance of clean utilities such as purified water, WFI, clean steam, compressed air, and nitrogen systems.
   • Ensure consistent utility quality and availability for manufacturing operations.
   • Conduct periodic audits and ensure compliance with pharmacopeial standards.
   • Collaborate with validation and QA teams for utility system qualification and requalification.
4. Leadership & Compliance
   • Lead a team of engineers and technicians; provide training and development.
   • Ensure compliance with cGMP, EHS, and regulatory standards.
   • Prepare and manage engineering budgets and maintenance KPIs.
   • Support audits (internal, external, regulatory) and implement CAPAs.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Mechanical/Electrical Engineering.
• Minimum 10+ years of experience in pharmaceutical/biotech/FMCG industry.
• Strong knowledge of GMP, HVAC, clean utilities, and process equipment.
• Experience in managing cross-functional teams and engineering projects.
• Proficiency in AutoCAD and MS Office tools.

Key Skills:

• Technical expertise in equipment and utility systems
• Leadership and team management
• Problem-solving and decision-making
• Project management
• Regulatory compliance and documentation

Equal Opportunity Statement: Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.