Senior Manager – Engineering

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization

Required Experience - 10+ Years.

Location - Johore, Malaysia.

Key Skills - Engineering & Maintenance

Role - Senior Manager - M&E

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.

1. 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.

1. 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.

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

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, and no employee shall be discriminated against because of their 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.