Susheel mishra

# Professional Profile

A highly experienced Pharmaceutical Maintenance and Projects Engineer with **14 years of proven expertise** in pharmaceutical manufacturing, engineering maintenance, plant reliability, and capital project execution. Skilled in managing preventive, predictive, and corrective maintenance programs while ensuring maximum equipment availability, regulatory compliance, and operational efficiency.

Extensive experience in executing greenfield and brownfield projects, including equipment installation, commissioning, qualification support, utility systems, and facility upgrades in compliance with GMP, cGMP, and international quality standards. Strong knowledge of pharmaceutical utilities such as HVAC, purified water systems, compressed air, steam systems, chillers, boilers, and production equipment.

Certified in **ISO 9001:2015 (Quality Management System)** and **ISO 45001:2018 (Occupational Health & Safety Management System)**, with a strong commitment to quality, safety, continuous improvement, and regulatory compliance.

Possess excellent leadership, problem-solving, project management, and cross-functional coordination skills with a successful track record of delivering projects on time and within budget. Experienced in leading maintenance teams, managing contractors, conducting root cause analysis, implementing CAPA, optimizing maintenance strategies, and driving continuous improvement initiatives to enhance plant performance and equipment reliability.

### Core Competencies

* Pharmaceutical Plant Maintenance
* Preventive, Predictive & Breakdown Maintenance
* Project Planning & Execution
* Equipment Installation & Commissioning
* Utility Systems Management (HVAC, PW, WFI, Compressed Air, Steam, Chillers, Boilers)
* GMP, cGMP & Regulatory Compliance
* ISO 9001:2015 & ISO 45001:2018
* Root Cause Analysis (RCA) & CAPA
* Maintenance Planning & Scheduling
* Engineering Documentation & SOP Management
* Budgeting & Cost Control
* Vendor & Contractor Management
* Risk Assessment & Safety Compliance
* Team Leadership & Cross-functional Coordination
* Continuous Improvement & Reliability Engineering