Maintenance Manager

Responsibilities:

• Team leadership and development

• Supervise, train, and mentor a team of engineers, technicians, and fitters.
• Conduct performance evaluations and promote a culture of continuous improvement.
• Organize and conduct training programs for the team to ensure technical competency and adherence to regulatory requirements.

• Compliance and documentation

• Ensure all maintenance activities are performed in strict adherence to cGMP, USFDA, EU GMP, WHO, and other regulatory guidelines.
• Lead and support regulatory audits and customer inspections related to engineering and maintenance.
• Maintain meticulous equipment history cards, asset registers, and all documentation for validation and qualification activities.
• Generate, review, and update maintenance SOPs and relevant protocols.

• Project management

• Manage capital projects, including the installation of new equipment, facility modifications, and process automation upgrades.
• Liaise with vendors and contractors for new installations, upgrades, and specialized repair work.
• Ensure all projects are completed on time, within budget, and in full regulatory compliance.

• Inventory and resource management

• Manage spare parts inventory, monitoring stock levels and generating purchase orders as necessary.
• Inspect and approve materials received from stores to ensure quality and suitability.
• Manage relationships with external service providers and contractors.

• Safety and environment

• Ensure full compliance with all health, safety, and environmental (HSE) regulations, including handling hazardous materials and implementing lockout/tag-out procedures.
• Implement and manage safety norms and firefighting measures.

Required Skills:

• Expertise in utility systems specific to injectable plants (HVAC, WFI, PW).
• Strong knowledge of cGMP regulations and validation/qualification protocols.
• Proficiency in maintenance techniques such as TPM, RCM, FMEA, and Root Cause Analysis.

Required Qualification: -