Your Name
Pune,MAHARASHTRA
Summary
Dynamic Team Leader Engineering (CQ & V), with 17+ years of progressive experience in the Pharma industry. Offering expertise in, Commissioning & Qualification with aptitude in project management. Quality Assurance documentation, Validation in GMP environment to meet the life science & health care industries. Energetic self-starter and team builder able to navigate high-stress situations and achieve goals on time through diligent work-ethic and dedication.
Overview
18
18
years of professional experience
Work History
Team Leader – Engineering (CQ & V)
Steils Biopharma Pvt. Ltd.
7 2023 - Current
- Responsible for Commissioning & Qualification of Process vessel, Vial line, Cartridge line, PFS line, Terminal sterilization line etc
- Responsible for review of isometrics drawings of process vessels pipelines
- Responsible for verification of pipeline slopes & dead legs in pipelines
- Responsible for review & approval of P & ID drawings of clean utilities & process equipment’s
- Responsible for Commissioning & Qualification of Purified water generation & distribution system, Water for Injection generation & distribution system, Pure steam generation & distribution system etc
- Project execution for clean utilities & process equipment’s etc
- Responsible for review & approval of URS, DQ, IQ, OQ & PQ of the equipment’s
- Prepares/Review the qualification & Validation activities for process equipment/Utility systems (Process vessel, Vial line, WFI/Purified water system, pure steam/compressed air/nitrogen air distribution systems, etc.) HVAC systems including clean air equipment (Dynamic Pass box, LAF, Bio safety Cabinet etc.) Process equipment’s (Autoclave, Isolator etc.)
Manager – Engineering (Project & Documentation)
Macleods Pharmaceuticals Pvt. Ltd.
06.2018
- Responsible for Commissioning & Qualification of Fermentation, Reactor, Purified water system etc
- Responsible for review of Isometric drawings of pipeline for process vessels
- Responsible for handling the vendors for execution of projects as per company requirement
- Responsible for qualification activities for process equipment, Utility systems (WFI/Purified water system, pure steam/compressed air/nitrogen air distribution systems, etc.), HVAC systems including clean air equipment (Dynamic Pass box, LAF etc.) Process equipment’s (VTD, TD, Blender, Compression etc.) and documentation such as URS/DQ/IQ/OQ.etc
- Modification of PLC/SCADA as per 21 CFR part 11 requirements (Compression machine, Auto coaters, Stability chambers, Water systems etc.) External / Regulatory Agency Audit handling Presentation and handling of qualification documents to External Auditor (Regulatory Agency) like USFDA, MHRA, WHO, EDQM, ANVISA etc
- Internal Auditor Periodic audit inspections for Utility systems (Water, steam) and HVAC systems to verify compliance to cGMP and regulatory guidelines
- Document Review and Maintenance Preparation /Review of SOP used in Pharma engineering along with the SOP required for the facility and utility systems Experience in preparation / maintaining change control documentation, event and CAPA documents by using application software like Track wise
- Reviewer of engineering documents like qualification, facility layouts, P&ID etc
- Completion of Water Systems periodic review Validation Well known with Validation activity for Water system, HVAC & other utilities
- Ensured consistent adherence to pharma guidelines regulations and legislation to maintain the compliance
- Monitored system functioning closely, troubleshooting and resolving issues
- Project Handling Project Planning, managing and coordination of/with vendors to ensure consistent smooth running of qualification of systems
- Spear headed special projects and resolved complex problems that impacted management and business direction
- Continually met targets through dedication to the work.
Assistant Manager Engineering
Emcure Pharmaceuticals
08.2006 - 06.2018
- Responsible for operation & maintenance of Purified water system, WFI system & Pure steam etc
- Responsible for maintenance of Q.C equipment’s like Stability chambers, Incubators, Cold chambers, Autoclaves etc
- Project: Installation & commissioning of Purified water system, WFI system & Pure steam etc
- Installation & commissioning of Process equipment’s like Lyo philizer, CRABS, ORABS etc
- Documentation & Quality management system (QMS): Responsible for preparation of SOP’s for engineering equipment’s
- Preparation of DQ, IQ, OQ of equipment’s by referring vendor’s documents & manual
- Responsible for raising the change control, deviation etc
- Responsible for CAPA (Corrective & Preventive action) implementation
- Responsible for conduction of training.
Skills
Installation, Commissioning, Qualification & Validation
Vendor management & Qualification
Team leading & training of team
Risk assessments
Corrective action plans
Team Leadership
Operations Management
Strategic Planning
Performance Management
Education
- Deccan institute (MSBTE), Advance Diploma in Industrial safety
- YCMOU (MSBTE approved), Diploma in Mechanical Engineering
- Pune University, Bachelor of Science
Softwareandapplication
- E Validation (Val genesis)
- SAP MM & PM module
- QMS software (Trackwise, EDMS, E-log etc.)
- Microsoft 365 (Office, Excel, Power point etc.)
- BMS, EMS, SCADA, ICDAS etc.
Reference
Reference will be provided if asked.
Communication - Languagesknown
- English
- Marathi
- Hindi
Timeline
Manager – Engineering (Project & Documentation)
Macleods Pharmaceuticals Pvt. Ltd.
06.2018
Assistant Manager Engineering
Emcure Pharmaceuticals
08.2006 - 06.2018
Team Leader – Engineering (CQ & V)
Steils Biopharma Pvt. Ltd.
7 2023 - Current