Open To Work
Mahesh Madhukar Handage
Cork,Ireland
Work Preference
Summary
Pharmacist with 15 years of experience in Commissioning & Qualification, Validation, Sterile Manufacturing.
Highly proficient Validation Engineer recognized for productivity and efficiency in task completion. Skilled in protocol development, risk analysis, and regulatory compliance, ensuring projects meet stringent quality standards. Excel in problem-solving, collaboration, and adaptability, leveraging these soft skills to drive success in fast-paced environments. Committed to continuous improvement and innovation to achieve operational excellence.
Overview
17
17
years of professional experience
4020
4020
years of post-secondary education
Work History
Validation Engineer
SANMINA IRELAND UC
Fermoy, Ireland
07.2024 - Current
- Drive facility/Utility qualification initiatives delivering consistent operational excellence through systematic validation procedures.
- Working on Design Review, Master Validation Plan, Commissioning & Qualification / Validation of facilities & Utilities, Preparation of User Requirement Specifications, Review of P&ID & Technical specifications, Preparation of SLIA, CLIA & QRA, Preparation and Execution of Design Qualification, Commissioning Protocols, IQ/OQ/PQ protocols.
- Grade ISO 8/ISO9 Cleanroom Project Planning and Scheduling of Executions of Qualification phases. Periodic qualification of the cleanrooms.
- Environmental monitoring system setup and qualification for routine monitoring.
- Thermal mapping for storage rooms, storage /lab equipments (Fridges, Incubator etc.)
- Executed process validations and measurement system analysis enhancing process accuracy and reliability in SMT. Managed new product validations, facilitating successful market entry and customer satisfaction.
- Handling of Change control, Deviations and CAPAs
- Fermoy, Ireland, facility is FDA registered and certified to ISO 13485 and MDSAP (Medical Device Single Audit Program) for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoy's core specialization is manufacturing automation. Sanmina provide services for the entire product life cycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair.
Manager Validation
PAR HEALTH
Indore, India
08.2021 - 07.2024
- Led Greenfield project execution and validation team of 10 members, orchestrating equipment commissioning for DARA PFS+Vial combi line with Isolator technology.
- Commissioning and Qualification of Grade A/C Cleanroom facility for sterile manufacturing.
- Working on Design Review, Master Validation Plan, Commissioning & Qualification / Validation of facilities & Utilities, Preparation of User Requirement Specifications, Review of P&ID & Technical specifications, Preparation and Execution of Design Qualification, Commissioning Protocols, IQ/OQ/PQ protocols.
- Sterilization, Fill-Finish Line, Isolator, LAF, HVAC, Cleanroom, Solution Prep. System, Terminal sterilization & packing line Qualification.
- Thermal Mapping for Rooms and Storage Equipment's.
- Involved in FAT/SAT of the major Equipments.
- Streamlined equipment commissioning activities through systematic planning and execution, enhancing operational efficiency and quality standards.
- Implemented risk mitigation strategies for sterile process validation, establishing robust protocols and ensuring regulatory compliance.
- Optimized equipment commissioning timelines through strategic planning, reducing validation cycles while maintaining quality standards through bracketing strategy approach.
- Handling of Validation procedure, requalification planner, change control, investigation, CAPA, Audit Response etc.
- The Par Health Indore site is a US FDA-approved, Greenfield-developed facility dedicated to generic sterile injectables. It produces a wide array of sterile products, including liquid vials, lyophilized vials, and prefilled syringes, utilizing both aseptic and terminally sterilized manufacturing processes.
Sr.Executive Validation/ Team Lead Validation
Mylan Laboratories Ltd. (Viatris)
Bengaluru, India
03.2015 - 08.2021
- Executed brown field project, site expansion qualification for dry powder injectable site.
- Involved in remediation plan for USFDA with LACHMAN consultant.
- Led validation of complex systems, ensuring compliance and operational efficiency. Streamlined vendor management, resulting in improved service delivery.
- Developed strategic project plans, Master validation Plan enhancing team collaboration and execution.
- Developing Master Validation Plan, IQ/OQ/PQ/RQ protocols.
- Involved in FAT/SAT for equipments.
- Managed budget and inventory, optimizing resource allocation and cost control.
- Qualification of following Pharmaceutical systems: Qualification of Vial Fill Finish Line, Qualification of HPHV Steam Sterilizer, Qualification of Purified Water System and Water for Injection System, Airflow Visualization for Aseptic processing, Qualification of compressed gases e.g. Nitrogen, Compressed air, Qualification of HVAC & Clean Room (ISO 5,6,7,8 & 9), Qualification of Online Particle monitoring, Qualification of Environment Monitoring System, Qualification of X-Ray Inspection Machine, Qualification of Packing Line including Serialization and Aggregation System, Qualification of Device assembly Machine, Qualification of LAF'S, ISOLATOR, PASSBOX, MOBILE CART, Temperature monitoring for storage equipment's and warehouse areas.
- Handling of Validation procedure, requalification planner, change control, investigation, CAPA, Audit Response etc.
- The Mylan Bangalore unit, now under the umbrella of Viatris-a new global healthcare company-is an USFDA and MHRA-approved injectable site. It specializes in the production of Dry Powder Penicillin, Cephalosporin, and generic liquid injectable.
Executive/Sr.Executive- Production
Hospira Healthcare India Pvt. Ltd. (Pfizer)
Vizag, India
11.2011 - 03.2015
- Involved in setting up Green field project for IMA Fill finish line.
- Project planning and execution, ensuring timely completion and resource optimization.
- Managed equipment procurement, conducting comprehensive vendor assessments and technical evaluations for optimal selection.
- Prepared URS and conducted risk assessments for cleanroom instruments.
- Involved in Qualification IMA Fill Finish Line (600 VPM) and ADAM solution prep. systems.
- Executed qualification protocols for clean room operations, including IMA Fill Finish Line and ADAM manufacturing systems.
- Developing Production procedures and day to day logs.
- Involved in implementing SAP-based electronic batch records while managing cross-functional teams.
- Coordinated technology transfer initiatives, reviewing critical documentation and supporting scaleup activities for pharmaceutical production.
- Designed conceptual layouts for pharmaceutical facilities, optimizing workflow in clean rooms, warehouses, and processing areas while ensuring compliance.
- The Hospira Vizag unit, now under the umbrella of Pfizer is an USFDA approved injectable site. It specializes in the production of large scale terminally sterilized generic liquid injectable with the high speed fill finish lines.
Executive - Production
AGIO Pharmaceuticals Ltd.
Pune, India
08.2009 - 11.2011
- Managed injection production logs, ensuring accurate daily updates and compliance.
- Coordinated weekly production plans, achieving seamless execution and target fulfillment.
- Oversaw media fill activities, maintaining thorough documentation and process integrity.
- Supported QA in validation and equipment qualification, enhancing operational standards.
- Conducted batch record reconciliation, ensuring precision in production documentation.
- AGIO Pharmaceuticals ltd. Pune is producing different dosage forms viz. Tablet, Capsules, Syrup and small volume parenterals for supply to the ROW Market including Ukraine, Russia, Sri Lanka etc.
Education
Master of Business Administration - Operations
University of Pune
Pune, IndiaBachelor of Pharmacy -
DYPIPSR, University of Pune
Pune, IndiaSkills
- Commissioning & Qualification
- Green field/ Brown Field Pharmaceutical Project
- Remediation/ Compliance against the Regulatory Audit
- Heating Ventilation & Air Conditioning System (HVAC)
- Sterile Fill Finish line
- Sterilization
- Thermal Mapping
- Documentation/QMS System: Agile
- Documentation/QMS System: Veeva
- Documentation/QMS System: Trackwise
Audit Exposure
- Regulatory audits like USFDA, MHRA, TGA, ANVISA, MCC, WHO, Health CANADA, MDSAP and ISO.
- Global/Customer/Internal Audits
Personal Information
Date of Birth: 07/01/87
Profile Snapshot
Pharmacist with 15 years of experience in Commissioning & Qualification, Validation, Sterile Manufacturing.
Professional Highlights
- 2 years serving as a Validation Engineer working on Commissioning & Qualification / Validation of Facility, HVAC & Utilities of Medical device company
- 3 Year serving as a Validation lead in Green field project focused on Installation, Commissioning and Qualification of Sterile Manufacturing Site.
- 6 years serving as a Validation lead & Executioner, working on Commissioning & Qualification / Validation of Facility, Equipment, HVAC & Utilities of Dry powder and General injectable manufacturing site.
- 3 years serving as a Production Executive involved in the Greenfield project of terminally sterilize injectable block. Working on Procurement, commissioning and qualification of fill finish line.
- 1.5 Years serving as a Production Executive in ampoule manufacturing site responsible for day to day production compounding, filling and visual inspection operation.
Languages
Marathi
First Language
English
Proficient
C2
Hindi
Advanced
C1
Timeline
Validation Engineer
SANMINA IRELAND UC
07.2024 - Current
Manager Validation
PAR HEALTH
08.2021 - 07.2024
Sr.Executive Validation/ Team Lead Validation
Mylan Laboratories Ltd. (Viatris)
03.2015 - 08.2021
Executive/Sr.Executive- Production
Hospira Healthcare India Pvt. Ltd. (Pfizer)
11.2011 - 03.2015
Executive - Production
AGIO Pharmaceuticals Ltd.
08.2009 - 11.2011
Master of Business Administration - Operations
University of Pune
Bachelor of Pharmacy -
DYPIPSR, University of Pune