Experience

Praj HiPurity Systems

• India
• Machinery Manufacturing
• 200 - 300 Employee

• Deputy General Manager -Process Design

  • Jul 2022 - Present

• AGM- Process Design

  • Jan 2021 - Jun 2022

• AGM- Technical Market Connect (MPS)

  • Aug 2019 - Jan 2021

  • Understand the URS and Project/ Process requirement of Bio Pharma & Pharma companies segmenting SVP, LVP, Microsphere, NDDS, Ophthalmology, Liquid Orals, Ointment for new Process Equipments as Process Vessels, Reactors, Fermenters, SIP & CIP skids, Bio kill tank / Inactivation system & interconnecting lines. Prepare P&ID & Technical offer• Review and ensure that, P&ID & BOQ to have correct features, correct size, process details and quantity. • Review and ensure P&ID to have proper SIP & CIP flow path for Vessels as well for all transfer lines.• Discuss with client for further process requirement and finalize the design. Assist BD team to explain the process to the client • Train the team to prepare FMEA/ Risk Assessment. Also explain and get approval on Risk Analysis from customers and consultants, as the case arises• During design phase train Proposal & Documentation Team to mitigate issues arising at FAT and SAT.• Thermal mapping SME Support to internal team and customer.

• AGM- FAT ( Factory Acceptance Test)

  • Dec 2015 - Aug 2019

  • Heading the Factory Acceptance Test (FAT) Department for modular process systems as Process Vessels, Reactors, Fermenters, SIP & CIP skids,• Development of the FAT facility in manufacturing Unit as per Global requirements,• Providing Technical inputs in design of pharma, Bio-pharma process equipment.• Wet trails of Process sequences like PHT, ESIP,FSIP, Batch & Transfer in for Process Equipment at factory level as per Control Philosophy/ Valve Matrix.• Thermal mapping of Process Vessels, skids as and when required during FAT • Review and Approve the FAT Documents.• Managing the resources for factory acceptance test.• Ensure the GMP & GEP compliance.• Ensure Verification of Tanks, Tubes Fittings, Pendants, Heat Exchangers ( Dimension Reports, Surface finish Testing Reports, Heat Charts, MOC, Radiography, Hydro test Reports, Riboflavin test report) received from QC engineer.• Ensure Verification of Test Certificates of Instruments, mounted on skid, tank and loose accessories• Accept or reject raw materials and finished products against client requirement/specification.• Provide inputs for 3D design drawing of process systems.



Jacobs

• United States
• Business Consulting and Services
• 700 & Above Employee

• Sr. Engineer- Project & CQV

  • Jan 2014 - Dec 2015

  •Managing the overall Commissioning , Qualification & Validation (CQV) project assignment for Pharmaceuticals and Biotechnology field.•Assist for developing project scope statements, estimates and proposals.•Reviewing & monitoring the project progress based on base line schedule with final accountability of project co-ordination & CQV. •Preparation of User Requirements Brief (URB) for different Projects, User Requirements specification (URS) for equipments/packages ,preparation of Project plan, •Assist for design co-ordination.•Responsible for vendor document review, vender quotations -technical bid analysis (TBA), •Handling functions of certifying vendors invoices/bills, rate analysis, extra item evaluation.•Managing preparation, execution, report compilation & review of qualification & validation protocols (IQ, OQ, PQ, and FV) and checklists, SLIA, CLIA.•Good knowledge of GMP and regulatory requirements , ISPE, ICH ASTM, ASME, APIC Guidelines.•Involved in all validation cross functional teams at the site to ensure adherence to required policies and procedures.•Monitoring the testing of all equipments, facilities, utilities & submit all required documents to the client project & validations team.•Conduct self inspection / internal audit.•Knowledge of process equipment used in development and manufacture of OSD•Coordinate with vendor and client for all required information for validations, monitor the validation schedules and actual validation activity, review the Validation & project snags/Closure list/reports, •Hand-over the project to engineering dept and user, demonstrate and train on operational aspects and facilities to the engineering team, periodically review with stakeholders to map the requirements with delivery.

• Engineer-Project & CQV

  • Mar 2012 - Dec 2013

  Jacobs Engineering India Pvt Ltd, Pharmaceuticals and Biotechnology field in Projects & Commissioning, Qualification, Validation (CQV) services



USV PRIVATE LIMITED

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Manager-DSP ( Biologics)

  • Apr 2011 - Mar 2012

  • Working in Down Stream Processing on Process optimization & purification of Protein,• Handling scale up, Process Development Experiments in pilot plant as well as conducting batches in GMP area• Responsible to maintain GMP area• For new equipments, preparation of URS, Review Design Qualification, GA drawing , P & ID,• Experience of executing FAT, SAT, IQ, OQ, PQ for New process equipment• For qualification of existing facility, preparation and of documents like, SLIA, CLIA, system Suitability test, VQ, IOQ, PQ and execution of same•Co ordinate with project department-- electrical line diagram, Equipment layout, clean utility, raw utility, drain points as per process requirements• Pre-commissioning, commissioning and start-up of all process equipment, Sanitization / Sterilization and validation• Effective and timely engineering support to core manufacturing process operations

• Sr Executive-DSP (Biologics)

  • Mar 2006 - Mar 2011

  •Working in Down Stream Processing on Process optimization & purification of Protein,•Handling scale up, Process Development Experiments in pilot plant as well as conducting batches in GMP area•Responsible to maintain GMP area•Member OF Validation Team, Validation of Autoclave, DHS, CIP System, SIP System, Process Vessels•Preparation of documents related to process like SOPs & BMR, MFR•Planning for New Product according to Process in Multi-product Facility •Verification of proper functioning of equipment and associated facility after receiving the equipment after maintenance•Member of Safety Committee



Wockhardt Ltd.

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assist Production Engineer Downstream Processing

  • Apr 2004 - Mar 2006

  • Involved in Pre-commissioning, commissioning and start-up of all process equipment and plant• Set up & stabilized Day tank Area and Solvent recovery unit• Working in Down Stream Processing on purification of recombinant Human Insulin• Gain experience of purification of recombinant protein, r-Human Insulin• Handling Reverse phase HPLC (Analytical & Preparative)• Handling Distillation unit (Azeotropic) for solvent Recovery purpose • Handling High vacuum Distillation• Characterization under cGMP guidelines & preparation of documents related to process like IQ, OQ ,PQ, SOP , BMR• Monitoring & Maintaining all process parameters as per requirement



Rukhama Industries

• Production Engineer

  • Jun 2001 - Mar 2004

  • Handling Distillation Unit.• Handling Shift operations.• Handling Vacuum Tray Drier, Centrifuge, K F Titrater• Handling various pumps & its maintenance.• Maintaining cooling tower & utility lines for plant.• Handling labor Management.• Production planning for achieving the monthly target.• Handling processes as settling & layer separation • Handling Distillation Unit.• Handling Shift operations.• Handling Vacuum Tray Drier, Centrifuge, K F Titrater• Handling various pumps & its maintenance.• Maintaining cooling tower & utility lines for plant.• Handling labor Management.• Production planning for achieving the monthly target.• Handling processes as settling & layer separation