Summary
Skills
Work History
Accomplishments
Education
Synopsis
Corecompetencies
Strengthprofile
Personal Information
Overview
Generic
Sunil Pandurang Ughade

Sunil Pandurang Ughade

Jalna

Summary

Seeking assignments in Engineering, Project with an organization of repute in the pharmaceutical Sector

A dynamic and results-driven professional with over 22 years of extensive experience in Oncology Projects and Engineering, specializing in Injectable, Oral Solid Dosage (OSD), Utilities, HVAC Qualification, and Water Systems. Currently serving as Director of Project & Engineering at Orion Lab, Oran, Algeria (North Africa), leading critical pharmaceutical infrastructure projects with precision and excellence. Proven expertise in driving end-to-end project operations, ensuring timely achievement of goals while optimizing resources and maintaining cost-effectiveness. Deep understanding of global regulatory frameworks, including cGMP, WHO, ISO, USFDA, and MHRA standards, ensuring compliance in all operational environments. Highly skilled in developing and establishing new facilities, including department setup, documentation processes, and adherence to stringent regulatory requirements. Known for exceptional leadership, adaptability, and the ability to deliver innovative solutions in complex project scenarios. Global Experience: Managed projects across Algeria, India, USA

Skills

  • Team leadership , Project management ,Strategic planning
  • Performance evaluation ,Resource allocation ,Decision making
  • Process improvement , Budget management
  • Skilled in MS Office, AutoCAD, and SAP
  • Kpi analysis , Operational efficiency , Staff training ,Goal setting
  • Time management , Communication skills
  • Problem solving , Vendor management
  • Negotiation skills, Performance tracking, Motivational skills
  • Workforce planning , Cost control ,Team building
  • Leadership development , Decision-making
  • Complex Problem-solving, Documentation and reporting

Work History

Director of Engineering & Project

Orion Lab
09.2024 - Current
  • Planning & Control Key role-playing to designing of injectable, Utility as well as oral solid plants
  • Implementing effective techniques to bring efficiency improve quality & achieve maximum cost savings
  • Selecting, evaluating and approval of vendors for procuring necessary input materials conforming to designed quality parameters
  • Process / Project Management Undertaking equipment installation and validation, for a control on process parameters to get optimum result with the safety of manpower and equipment
  • Reviewing proper documentation viz
  • DQ, IQ, OQ, PQ, PMP, Sop’s etc as per requirement of cGMP & Quality standards
  • Monitoring detailed documents explaining about work and its results
  • Reviewing and preparing BOQ for the mechanical (Water system, HVAC, Utility) as well as Electrical for new project
  • Facility designing for Oncology Injectable as well as Oral Solid
  • Cost Reduction Initiatives Analyzing various processes / applications and recommending process changes, equipment calibrations to initiate cost savings and enhance operational efficiency
  • Executing cost saving and energy saving techniques/ measures and modification to achieve reduction in cost within the budget

Associate Director of Engineering & Project

Tailstorm Health Inc
03.2020 - 08.2024
  • Design and execution of Greenfield Projects, including Injectable and PFS Blocks, Quality
  • Control, and Microbiology areas
  • Directed end-to-end project management, encompassing Utilities, HVAC, Electrical, Civil, Mechanical
  • Modular Panels, and Process Equipment installation
  • Strategized and implemented detailed project plans, ensuring milestones were achieved within budget and timelines
  • Led equipment selection, FAT approvals, and P&ID reviews while overseeing BOQs for HVAC
  • Electrical, Mechanical, and Civil works
  • Optimized water system design, consumption analysis, and procurement planning to meet project demands
  • Evaluated and finalized vendor contracts, ensuring timely procurement and material delivery
  • Supervised cross-functional teams for seamless execution of Civil, Utility, Electrical, HVAC, and
  • Modular Panel works
  • Managed qualification protocols, including URS, DQ, FAT, SAT, IQ, OQ, and PQ, ensuring regulatory compliance
  • Championed safety standards, integrating advanced systems like Door Interlocking, Smoke Detection
  • CCTV, and BMS
  • Delivered high-quality projects through collaboration, innovation, and robust stakeholder engagement.

Manager Engineering & Project

Orion Lab Oran
06.2018 - 02.2020
  • Designed and executed Oncology Greenfield Projects for Injectable and Oral Solid Blocks, ensuring compliance with GMP standards
  • Development of Quality Control and Microbiology areas to meet stringent pharmaceutical requirements
  • Integrated Utilities, HVAC, Electrical, and Safety Systems, including Door Interlocking, Smoke
  • Detection, CCTV, and BMS, for a robust infrastructure
  • Managed Civil, Mechanical, Modular Panels, and Process Equipment installation with precision and efficiency
  • Conducted project planning and execution, aligning milestones with timelines and budgets
  • Supervised equipment selection, conducted kick-off meetings, and ensured FAT approvals for critical machinery
  • Directed HVAC system design reviews, ducting, and utility line layouts to optimize functionality
  • Prepared and reviewed BOQs for Electrical, HVAC, Mechanical, and Civil components, ensuring cost- effectiveness
  • Optimized water system design, consumption analysis, and procurement for seamless operations
  • Oversaw vendor negotiations, finalized contracts, and ensured on-time delivery of materials
  • Verified daily on-site activities, ensuring adherence to project plans and high-quality execution
  • Supervised installation of Granulation Lines, Compression Machines, Capsule Fillers, Coating Machines
  • Autoclaves, and R&D equipment across multiple locations, including the UK, Germany, and Italy
  • Led FAT processes for critical equipment like GEA, Horro Hofliger, Glatt, Optima, and Still Mass systems
  • Delivered successful HVAC installations, including ducting and AHU systems, ensuring GMP compliance
  • Ensured smooth execution of Civil work, Utility equipment, Modular Panel, Electrical, and HVAC projects
  • Directed qualification activities, including URS, DQ, FAT, SAT, IQ, OQ, and PQ, to meet regulatory standards
  • Orchestrated design and execution of vial washing, filling, LYO, and stoppering systems with isolator technology
  • Collaborated with global teams across the UK, Germany, Italy, and India to deliver innovative solutions
  • Championed safety and security systems for enhanced operational reliability and compliance
  • Achieved excellence through leadership, meticulous planning, and cutting-edge engineering practices.

Manager

Shilpa Medicare limited
12.2014 - 06.2018
  • Project Design and Conceptualization
  • Design of Greenfield projects, including Oncology Injectable, OSD, and Combined Injectable & OSD Blocks
  • Directed modification projects for existing injection lines, including filling area upgrades
  • Oversaw PEB shed construction and developed electrical BOQs to support infrastructure needs Comprehensive Project Planning
  • Project plans encompassing scope, timelines, deliverables, and regulatory compliance (e.g., GMP FDA)
  • Aligned project objectives with organizational goals and ensured efficient resource allocation BOQ Preparation and Review
  • Prepared and reviewed BOQs for Electrical, HVAC, Mechanical, and Civil works to ensure cost efficiency and accuracy
  • Vendor Management
  • Evaluated vendor proposals, finalized vendor selections, and negotiated contracts for timely and cost- effective material delivery
  • Material Procurement and Coordination
  • Oversaw project material indenting, work order approvals, and follow-ups to maintain adherence to the project timeline
  • Stakeholder Collaboration
  • Collaborated with management to freeze drawings, specifications, and project requirements
  • Site Execution Supervision
  • Monitored on-site execution of Civil works, Utility equipment, HVAC systems, Modular Panels, and Process Equipment installations
  • Verified daily progress to ensure alignment with project schedules and quality standards
  • Safety and Security System Integration
  • Managed the installation and integration of safety systems, including Door Interlocking, Smoke Detectors, CCTV, and BMS
  • Regulatory Compliance and Qualification
  • Directed qualification processes for equipment, ensuring compliance with URS, DQ, FAT, SAT, IQ, OQ, and PQ standards
  • Vendor FAT and Equipment Validation
  • Conducted FAT for injectable line equipment in China (Tofflon), including Vial Washing, Filling Machines, Isolators, Autoclaves, and Capping Machines
  • Multi-Disciplinary Oversight
  • Supervised activities across Civil, Mechanical, Modular Panel, Electrical, and HVAC domains, ensuring seamless coordination and execution
  • Project Execution Excellence
  • Ensured that all project activities were executed as per the approved plan, adhering to the highest quality and safety standards
  • Risk Assessment and Problem-Solving
  • Identified project risks proactively and implemented mitigation strategies to avoid delays or cost overruns
  • Progress Monitoring and Reporting
  • Tracked project milestones, generated progress reports, and communicated updates to stakeholders effectively
  • Handover and Documentation
  • Ensured a successful project handover, including comprehensive documentation, equipment validation reports, and client satisfaction
  • Leadership and Innovation
  • Led cross-functional teams, driving innovation and implementing best practices to enhance project delivery.

Assistant Manager

Mylan Laboratories limited
03.2011 - 10.2014
  • RESPONSIBILITY
  • DOCUMENTATION
  • ENGINEERING RECORDS : Daily records of the water system, Utility, HVAC and Preventive
  • Maintenance
  • Area layouts
  • SOP : Preparation & Periodic review of Operational SOP’s
  • QUALIFICATION : Design, Installation, Operational & Performance qualification of HVAC & Compressed Air, Chiller, Boiler, DG Equipments
  • MISCELLANEOUS : Change Control, Deviations, Risk Management, and Impact Analysis of engineering equipment.

Sr. Executive

Ranbaxy Laboratories
12.2010 - 02.2011
  • ENGINEERING RECORDS : Water system operation record , Utility records, HVAC Daily records,
  • SOP : Preparation & Periodic review of Operational and preventive
  • Maintenance, SOP’s.
  • PREVENTIVE MAINTENANCE AND AUTOMATION : process area equipment preventive maintenance Modification in machine for maximum productivity & break down analysis of break down.
  • PLANNING : Preventive Maintenance , Calibration & Shift planning, Handling of man Power.

Junior Manager

Dr. Reddy's Laboratory
09.2006 - 12.2010
  • Proficient in documentation management, maintaining utility, HVAC, and daily engineering records with accuracy.
  • Skilled in the preparation and periodic review of operational and preventive maintenance SOPs, ensuring compliance with standards.
  • Experienced in qualification processes, including design, installation, operational, and performance qualification of equipment.
  • Managed change control, deviations, and incidents, ensuring streamlined operations and adherence to regulatory guidelines.
  • Conducted validation of engineering equipment and HVAC systems, guaranteeing efficiency and reliability.
  • Implemented preventive maintenance programs and automated modifications for enhanced productivity and reduced downtime.
  • Planned and executed preventive maintenance, calibration schedules, and manpower management to optimize resources.
  • Conducted internal and safety audits, facilitated departmental training, and ensured a safe and compliant work environment.
  • Successfully led machine installations and project execution, managing vendors and external stakeholders effectively.
  • Delivered key achievements, including the installation of advanced systems (IMA Kilian, Zanasi, Countec), leak testing of isolators, and preparation for audits such as USFDA, WHO, and ANVISA

Plant Electrician

PepsiCo
12.2002 - 09.2006
  • Installation of the process equipment
  • Established user friendly SOPs on shop floor.
  • Working on HT and LT line
  • Working on VCB, ACB, Transformer handling and their breakdown.
  • Control circuit wiring and panel wiring.
  • Work on Automation.
  • Working on Diesel Generator (D.G.) and its maintenance which includes A check, B check, C check and D check.
  • Regular Maintenance

Accomplishments

  • Participated in WHO, ANVIZA, USFDA, MHRA audits
  • Completed projects of Oncology Injectable and Dry Powder Combi line in Shilpa Medicare Ltd.
  • Design Part completed in Oncology project of Injectable and OSD block at Orion Lab Algeria

Education

DEE - Electrical

Dnyaneshwar Dnyanpeeth in ITS Management Campus
Aurangabad

Synopsis

  • Experienced Professional: Over 22 years of extensive experience in managing Oncology projects and pharmaceutical engineering, specializing in Injectable and Oral Solid Dosage (OSD) forms.
  • Leadership Roles: Proven expertise in strategic leadership roles, including Director of Engineering and Project Management in global pharmaceutical organizations.
  • Regulatory Expertise: Deep understanding of global regulatory frameworks, including cGMP, WHO, USFDA, MHRA, and ISO standards, ensuring compliance across projects.
  • Project Management Excellence: Skilled in end-to-end project management, encompassing planning, execution, resource allocation, vendor management, and cost control.
  • Technical Proficiency: Expertise in HVAC systems, water systems (WFI, RO+EDI), utilities, electrical systems, and advanced pharmaceutical equipment installation and qualification.
  • Innovative Problem-Solving: Adept at implementing process improvements, automation, and cost-saving initiatives to enhance operational efficiency.
  • Global Experience: Successfully managed and delivered projects across multiple countries, including Algeria, India, UK, Germany, and North Africa.
  • Team Leadership and Development: Demonstrated ability to build, mentor, and lead multidisciplinary teams to achieve organizational objectives.
  • Audit and Compliance Success: Successfully prepared for and faced international regulatory audits, including WHO, USFDA, and ANVISA.
  • Multi-Sector Expertise: Comprehensive experience in engineering domains, including HVAC, water systems, utilities, electrical, and packaging.

Corecompetencies

Designing and implementing strategies, Managing Project & Engineering Department, Designing injectable and utility plants, Implementing efficiency techniques, Equipment installation and validation, Documentation review, BOQ preparation, Analyzing processes for cost savings, Executing cost-saving techniques, Interfacing with people at all levels, Recruiting and mentoring juniors

Strengthprofile

Strongly believes in the concept of teamwork.

Personal Information

  • Blood Group: B
  • Date of Birth: 09/10/83
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Overview

22
22
years of professional experience

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Sunil Pandurang Ughade