21 Sep
|
DigiCAD
|
Ankleshwar
21 Sep
DigiCAD
Ankleshwar
Job Description:
Role Objective / Major Purpose of the Job
This role Senior Manager oversees preventive, predictive, and corrective maintenance programs, drives equipment reliability and operational excellence, and ensures compliance with current Good Manufacturing Practice (cGMP), environmental, health, and safety (EHS), and regulatory requirements.
Principal Tasks & Responsibilities
• Develop and execute maintenance strategies aligned with business and manufacturing objectives.
• Lead preventive, predictive, and breakdown maintenance programs for API manufacturing equipment, utilities, and facility infrastructure.
• Ensure high equipment availability and reliability while minimizing unplanned downtime.
• Oversee maintenance of reactors, centrifuges, dryers, filters, mills, blenders, HVAC systems, chillers, boilers, cooling towers, compressors, water systems, and other utility equipment.
• Drive reliability engineering initiatives using Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), Reliability-Centered Maintenance (RCM), and predictive maintenance techniques.
• Plan and manage annual maintenance shutdowns, plant turnarounds, and equipment overhauls.
• Manage maintenance budgets, capital expenditure (CapEx), operating expenditure (OpEx), spare parts inventory, and vendor contracts.
• Develop maintenance KPIs and drive continuous improvement using Lean Manufacturing and Total Productive Maintenance (TPM) principles.
• Solid understanding of API manufacturing equipment, plant utilities, and facility maintenance.
RO, DM, and PW generation systems (where applicable)
Pumps, piping, valves, and mechanical equipment
Preventive Maintenance (PM) procedures
User Requirement Specifications (URS)
CAPA documentation
Lead installation, commissioning, qualification, and validation of new equipment and utility systems.
Ensure compliance with cGMP, US FDA, EU GMP, WHO GMP, and other applicable regulatory requirements.
Key Skills & Competencies
Functional /
📌 Senior Manager (Ankleshwar)
🏢 DigiCAD
📍 Ankleshwar