M&E Assistant Manager/ Manager (Mechanical & Electrical)Biocon Biologics • JohorMalaysia, Johor, Malaysia

M&E Assistant Manager / Manager (Mechanical & Electrical)

Biocon Biologics • JohorMalaysia, Johor, Malaysia

8 days ago

Job description

M&E Assistant Manager / Manager (Mechanical & Electrical)

Responsible for leading the Mechanical & Electrical team to ensure reliable operation, preventive maintenance, project execution, and facility upkeep in compliance with GMP, EHS, and quality standards. The role also oversees new project implementation, qualification, and continuous improvement initiatives.

Key Responsibilities

Project & Validation

Review and approve new project documentation, design, and specifications.
Prepare overall project timeline and schedule; ensure timely execution and completion.
Support commissioning and validation activities including FAT, SAT, DQ, IQ, OQ, and PQ .
Review and approve qualification and QMS documents related to M&E systems.

Maintenance & Operations

Lead preventive and corrective maintenance of all plant and utility equipment to achieve zero unplanned downtime .

Maintain spare part availability and coordinate with vendors for servicing and repairs.

Ensure all systems operate according to manufacturer recommendations and GMP standards .

Monitor equipment performance, troubleshoot issues, and implement improvements proactively.

Oversee building maintenance and ensure DS facility upkeep.

Leadership & Compliance

Manage M&E team scheduling, delegation, and training.

Review vendor performance and approve maintenance schedules, materials, and work permits.

Drive compliance with EHS, QMS, and regulatory audits , ensuring timely closure of findings.

Participate in energy management , cost optimization, and continuous improvement projects.

Approve departmental claims, invoices, and leave requests.

Administrative & System Responsibilities

Ensure accurate documentation, logbooks, and maintenance records per SOPs.

Utilize SAP for maintenance notifications, work orders, and tracking.

Support internal and external audits, CAPA, deviation, and change control processes.

Requirements

Bachelor’s Degree in Mechanical / Electrical / Mechatronic / Industrial Engineering or related field.

(Diploma holders with strong experience will also be considered.)

Minimum 8 years of relevant experience in M&E / Facility / Utility maintenance, with at least 2 years in a managerial or supervisory role.

Experience in pharmaceutical, biotech, or manufacturing (GMP environment) is highly preferred.

Proven exposure to HVAC, cleanroom systems, water systems, compressors, chillers, and automation equipment.

Strong understanding of project management, validation, and qualification processes.

Good knowledge of EHS, QMS, and regulatory compliance.

Proficient in SAP or CMMS systems.

Excellent leadership, analytical, and communication skills.

Ability to manage contractors, vendors, and cross‑functional teams effectively.

About The Benefits

At Biocon, you’ll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym / sports room, and exceptional opportunities for career advancement.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Management and Engineering

Industries

Pharmaceutical Manufacturing

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Assistant Manager • JohorMalaysia, Johor, Malaysia

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