Dhiraj Agrawal
Engineer
Pune
Summary
Experienced Engineering Professional with a strong background in Greenfield projects for the Pharmaceutical and Biotech industries. Skilled in Plant Operation and Maintenance, specializing in Cleanroom Facilities, various Formulation lines with Filling and Secondary Packaging operations. Possess expertise in Biotech DS Process and Utilities. Proficient in maintaining compliance with cGMP norms and experienced in handling Regulatory Audits, including USFDA inspections. Possess extensive knowledge and experience in preventive and breakdown maintenance, with a strong focus on Quality Management Systems (QMS). Skilled in implementing Corrective and Preventive Actions (CAPA) and conducting Root Cause Analysis (RCA). Demonstrate competence in Validation, Deviation Management, and Standard Operating Procedures (SOPs). Having excellent attention to detail and problem-solving skills, ensuring efficient compliance and smooth operations.
Overview
28
28
years of professional experience
Work History
Assistant General Manager - Engineering
Enzene Biosciences Ltd
Pune
05.2024 - Current
- Company Overview: Enzene is a subsidiary of Alkem Laboratories.
- Acting as the Head Engineering, I am responsible for the oversight of multiple facilities including Biotech Unit-I DS, DP, Central Utilities, and Unit-II, Unit-III (R&D).
- Handling a team of 50+ engineers and technicians, providing guidance and supervision to ensure the smooth functioning of all operations.
- My responsibilities include managing Plant Maintenance, HVAC, Water systems, Instrumentation & automation, Central utilities, Electricals, R&D and Unit-II.
- Oversee the maintenance and operation of a diverse range of facilities, including process equipment such as Fermenters, Homogenizers, Centrifuges, Lyophilizers, Autoclaves, DHS, Process Vessels, Chromatography columns.
- Utility equipments like Reverse Osmosis and Electrodeionization followed by MCDP & PSG equipment, Air Handling Units, Air Compressors, Boilers, Chillers, Nitrogen Generator, Power house, and Solvent Yard.
- Responsible for Engineering compliance during audits.
- Recruit, motivate and direct the workforce to achieve organizational goals, resulting in increased productivity and operational efficiency.
- Notable accomplishments: Production Capacity Enhancement: Completed two facility expansion projects Microbial and mammalian including HVAC with BMS/EMS upgradation, Addition of new Bioreactors, Fermenters, Centrifuges, Autoclaves, Cold room etc including Installation - Commissioning, Qualification and hand over.
- Enzene is a subsidiary of Alkem Laboratories.
Sr. Manager - Engineering
M.J. Biopharm Pvt Ltd
Pune
09.2021 - 05.2024
- Department Head for Engineering and Utilities, I am responsible for the oversight of multiple facilities including Biotech DS, Pilot Plant, F&D, Central Utilities, and EHS.
- Handled a team of 70+ employees, providing guidance and supervision to ensure the smooth functioning of all operations.
- My responsibilities include managing Plant Maintenance, HVAC, Water systems, Instrumentation & automation, Central utilities, Electricals, and EHS.
- Oversee the maintenance and operation of a diverse range of facilities, including process equipment such as Fermenters, Homogenizers, Centrifuges, Lyophilizers, Autoclaves, DHS, Process Vessels, Chromatography columns.
- Utility equipments like Reverse Osmosis and Electrodeionization followed by MCDP & PSG equipment, Air Handling Units, Air Compressors, Boilers, Chillers, Nitrogen Generator, Power house, and Solvent Yard.
- Recruit, motivate and direct the workforce to achieve organizational goals, resulting in increased productivity and operational efficiency.
- I play a key role in maintaining cGMP standards through the effective implementation of Quality Management System (QMS) documentation within the department.
- Responsible for annual budget preparation and cost control for power, fuel, water, and maintenance expenses.
- Provide monthly reports to management, highlighting departmental performance in terms of operations, costs, and quality parameters.
- Notable accomplishments: Production Capacity Enhancement: Facility expansion including HVAC, Addition of new Fermenters, Centrifuges, Process Vessels, CIP and ancillary process piping, BMS/EMS upgradation etc. Utilities Capacity Enhancement: Addition of new Air compressors, Dryers, Chillers, Boilers, Nitrogen Generator, Solvent Tanks, Power Transformer, DG etc. Waste Handling: Vent Scrubbers, Biokill, Upgrading conventional ETP to green field Zero Liquid Discharge (ZLD) etp. Water System: Addition of new water Pretreatment and High Purity water system including CSRO, HSRO, EDI, MCDP, PSG with storage tanks and piping. Installed Tertiary RO for reject Recovery.
Associate Manager - Engineering
Zydus Lifesciences
Ahmedabad
05.2018 - 09.2021
- Company Overview: Formerly known as Cadila Healthcare Limited - Zydus Biologics.
- Worked at the Biologics unit formulation plant based in Ahmedabad, Gujarat. The plant is an USFDA approved formulation facility for injectables.
- I was responsible for leading engineering activities, including plant maintenance, HVAC, and water systems. My role involved both routine preventive maintenance as well as troubleshooting and resolving breakdowns as well handling Facility capacity enhancement project.
- Successfully managed the maintenance of a vial line with a Lyophilizer and a PFS De-bagger, Filling line with complete automated secondary packaging machinery like Denester, Optical Inspection, Leak Testing, Plunger rod insertion, Labeling etc. Additionally, one cartridge filling and packing line.
- In order to comply with the necessary regulations, ensured the maintenance of the facility and implemented modules such as SCADA, BMS, and FMS for monitoring and control of activities in accordance with 21CFR.
- As part of my responsibilities, also played a crucial role in the QMS (Quality Management System) by overseeing Qualification, Validation, Change Control, Deviation, CAPA, Audits, and ensuring compliance from the engineering perspective.
- Involved in Capacity Enhancement Project, including Facility & Equipment layouts, Man-Material flow concepts, HVAC design, Vendor evaluation and Equipment inspection.
- Consistently delivered high-quality results, meeting all compliance requirements and ensuring the smooth operation of the formulation plant.
- Formerly known as Cadila Healthcare Limited - Zydus Biologics.
Manager
Aseptic Fabrikon
Pune
10.2011 - 04.2018
- Company Overview: Family-owned business specializing in Stainless Steel Fabrication and Maintenance services for the pharmaceutical industry.
- Successfully managed a family-owned business specializing in Stainless Steel Fabrication and Maintenance services for the pharmaceutical industry.
- Successfully manufactured Process and Packing machinery for the pharmaceutical sector.
- Provided comprehensive on-site services to various Pharma clients, ensuring top-notch quality and customer satisfaction.
- Family-owned business specializing in Stainless Steel Fabrication and Maintenance services for the pharmaceutical industry.
Assistant Manager - Engineering
Emcure Pharmaceuticals Ltd
Pune
06.2010 - 10.2011
- Company Overview: Oncology Division.
- Managed and supervised a team of engineers and technicians to ensure efficient operation and maintenance of utility equipment, within the Oncology Injectables unit.
- Oversaw the maintenance and operation of various equipment, including boilers, chillers, air compressors, hot water generators, water treatment systems, condensate recovery systems, and scrubbers.
- Implemented preventive and breakdown maintenance strategies to minimize equipment downtime and optimize performance.
- Created and executed routine calibration schedules and documented the results, ensuring equipment accuracy and compliance.
- Conducted safety audits and consistently observed safety practices to ensure a safe working environment for all staff.
- Oncology Division.
Manager - Technical Support
Marchesini Group India Pvt. Ltd
Mumbai
10.2008 - 06.2010
- Company Overview: A Global organization, specializing in the manufacturing of Filling and Packaging machineries for the Pharmaceutical and other sectors, offering robotized fully automatic complete line solutions.
- Underwent comprehensive training on various machine ranges at manufacturing factories in Italy.
- Promoting sales of Marchesini Group Machines across India.
- Supporting customers in Techno-commercial evaluation, optimization, process bottleneck evaluation, layout feasibilities, etc.
- Taking care of after-sales services including troubleshooting and spare parts procurement.
- Coordinating with customers for new projects, including technical evaluation, equipment selection, up to equipment arrival and startup.
- Representing the company during various exhibitions and events on a national and international level.
- A Global organization, specializing in the manufacturing of Filling and Packaging machineries for the Pharmaceutical and other sectors, offering robotized fully automatic complete line solutions.
Assistant Manager - Engineering
Emcure Pharmaceuticals
Pune
10.2004 - 10.2008
- Company Overview: (Sterile Products Division)
- Led a team of Engineers and Technicians for the operation and maintenance of Plant Machinery, HVAC, Water System, and Calibration activities right from project Civil work up to plant operation and regulatory approval.
- Successfully implemented the installation and commissioning of various equipment including Fermentors, Centrifuges, Steam Sterilizers, Washing Machines, Depyrogenation Tunnel, Filling and Sealing Machines, and packaging lines at Biotech and Formulation Unit.
- Oversaw the set up of modular paneling, HVAC, water system, process piping, QC and Microbiology lab set up.
- Managed the installation and commissioning of vial lines, pre-filled syringe lines, and ampoule lines for formulation processes.
- Expertise in HVAC systems, including AHUs with BMS and MLS system for temperature and humidity control.
- Proficient in managing water systems such as DM plant, UF, multi-column water still, pure steam generator, and WFI system with on-line SCADA and TOC monitoring.
- Represented department during customer and regulatory audits, including USFDA. Led the team during these audits.
- Conducted internal quality audits and provided training to staff personnel.
- (Sterile Products Division)
Maintenance Engineer
Wockhardt Limited
Aurangabad
09.2000 - 10.2004
- Company Overview: (Biotech Park)
- Spearheaded the successful scale-up project of HBsAg, EPO, and Insulin products, overseeing the transition from R&D batches to full-scale production.
- Managed all aspects of the project, including green field project activities, civil structure, clean room paneling, and process equipment installation.
- Efficiently executed the commissioning, operation, and maintenance of the plant, including utility equipment.
- Demonstrated strong attention to detail and a focus on optimizing process efficiency.
- Demonstrated Flexibility and Adaptability by working in both project phases and shift operation activities, ensuring uninterrupted plant operations and timely project completion.
- (Biotech Park)
Maintenance Supervisor
J K Ansell Limited
Aurangabad
09.1997 - 09.2000
- Company Overview: Formerly known as J K Chemicals Limited, a joint venture between Raymond Group India and Pacific Dunlop Ltd Australia.
- Ensured plant maintenance was carried out efficiently and effectively.
- Played a key role in process optimization, system modification, and development.
- Developed and maintained strong relationships with vendors and effectively managed spare parts inventory.
- Managed a manufacturing line that included a chain conveyor system with glass formers, a latex dipping line, hydro extractor, tumblers, electronic testing machineries, sealing machines, and coding machines.
- Formerly known as J K Chemicals Limited, a joint venture between Raymond Group India and Pacific Dunlop Ltd Australia.
Trainee Supervisor Production
Anil Polymer Pvt Ltd
Aurangabad
06.1997 - 09.1997
- Company Overview: Well known for specialized packaging solutions.
- Handled shift operations which include planning, coordination and supervision of shift activities for Polystyrene Moulding machine shop.
- Well known for specialized packaging solutions.
Education
PGDBM -
University
Pune01.2010
Diploma - Mechanical Engineering
Board of Technical Education (BTE)
Government Polytechnic Jalna01.1997
12th - Science
Maharashtra
New English School, Jamner, Jalgaon - Maharashtra01.1993
10th - Marathi
Maharashtra
AGRGMV Shendurni, Jalgaon01.1991
Skills
- Project Planning
- Project Execution
- HVAC
- Water System
- Fermentation
- Biotechnology
- Formulation
- Pharma Machinery
- GMP Compliance
- Operation and Maintenance
- Windows
- Auto Cad
- SAP
- ERP
- Documentum
Personal Information
- Date of Birth: 03/20/76
- Gender: Male
- Mobile: 7588579636
Timeline
Assistant General Manager - Engineering
Enzene Biosciences Ltd
05.2024 - Current
Sr. Manager - Engineering
M.J. Biopharm Pvt Ltd
09.2021 - 05.2024
Associate Manager - Engineering
Zydus Lifesciences
05.2018 - 09.2021
Manager
Aseptic Fabrikon
10.2011 - 04.2018
Assistant Manager - Engineering
Emcure Pharmaceuticals Ltd
06.2010 - 10.2011
Manager - Technical Support
Marchesini Group India Pvt. Ltd
10.2008 - 06.2010
Assistant Manager - Engineering
Emcure Pharmaceuticals
10.2004 - 10.2008
Maintenance Engineer
Wockhardt Limited
09.2000 - 10.2004
Maintenance Supervisor
J K Ansell Limited
09.1997 - 09.2000
Trainee Supervisor Production
Anil Polymer Pvt Ltd
06.1997 - 09.1997
PGDBM -
University
Diploma - Mechanical Engineering
Board of Technical Education (BTE)
12th - Science
Maharashtra
10th - Marathi
Maharashtra