Sr. Manager - Engineering & Maintenance (API)

Education: B.E. / B.Tech in Mechanical / Electrical / Instrumentation / Chemical Engineering.

Experience: 12 to 18 Years in Engineering & Maintenance in a mid-sized API/Pharma plant, with a minimum of 5 years in a senior managerial role

Location: Vapi

Reporting To: Sr. VP Operations

Department: Engineering & Maintenance

Purpose of the Role:

To provide strategic leadership and operational excellence in managing plant engineering, utilities, and maintenance to support uninterrupted, compliant, and efficient API manufacturing operations. The role combines strategic engineering initiatives (capex, regulatory readiness, energy optimization) with maintenance operations (equipment reliability, preventive maintenance, troubleshooting), ensuring cGMP compliance and readiness for regulated markets.

Accountability Tracks

1. Strategic Engineering

* Develop and execute engineering strategies aligned with the organization’s business growth, expansion, and regulatory goals.

* Plan and implement capital investment projects (equipment upgrades, new facility setups, energy-saving initiatives).

* Ensure engineering systems and utilities comply with USFDA, EMA, and other global cGMP standards.

* Act as a subject matter expert during regulatory audits, inspections, and customer visits on engineering-related areas.

* Implement sustainability initiatives (energy efficiency, water management, effluent handling) to optimize costs and environmental impact.

* Drive innovation in engineering practices (automation, digital monitoring, advanced CMMS).

2. Maintenance Operations

* Ensure continuous availability and reliability of all plant equipment, utilities, and infrastructure.

* Lead preventive, predictive, and breakdown maintenance across production equipment, utilities (boilers, chillers, compressors, HVAC, WFI, RO/DM systems), and effluent treatment plants.

* Monitor and improve KPIs for equipment uptime, MTBF (Mean Time Between Failures), and MTTR (Mean Time to Repair).

* Ensure timely equipment calibration, qualification, and documentation in line with GMP.

* Drive quick and effective troubleshooting of equipment failures, minimizing impact on production schedules.

* Maintain engineering documentation (logbooks, SOPs, maintenance records) to ensure audit readiness.

* Enforce EHS compliance and promote safe practices across all engineering activities.

* Train, mentor, and develop engineering and maintenance teams to build strong technical capability.

Key Technical Competencies

* Strong knowledge of API/Pharma plant utilities and equipment.

* Expertise in preventive & predictive maintenance systems, preferably through CMMS.

* Familiarity with equipment qualification, calibration, and validation.

* Deep understanding of cGMP requirements and regulatory audit expectations.

* Knowledge of automation, instrumentation, and energy management practices.

Key Behavioral Competencies

* Strategic Thinking : Ability to align engineering roadmap with business and regulatory priorities.

* Problem-Solving : Structured approach to root cause analysis and technical troubleshooting.

* Collaboration: Strong cross-functional coordination with QA, Production, RA, and EHS.

* Leadership : Ability to inspire, coach, and retain a high-performing engineering team.

* Accountability : Ownership for plant reliability, compliance, and cost optimization.

* Agility : Ability to respond rapidly to equipment issues or audit demands.

Core Performance Dimensions

Dimension Success Indicators

Strategic Engineering Timely execution of capital projects; compliance of facilities/utilities with global GMP

Equipment Uptime Reduction in downtime, improved MTBF, adherence to maintenance KPIs

Preventive Maintenance ≥95% adherence to preventive/predictive maintenance schedule

Regulatory Compliance Zero major/critical audit observations in engineering & maintenance areas

Energy & Cost Optimization % savings in energy, water, and utility costs annually

EHS & Safety Zero safety incidents/accidents in the engineering domain

Team Capability Skill development, retention, and performance of the engineering team