Suneel Kumar

Professional Engineer, having a total 14.0 years of rich experience in Maintenance & Projects with cGMP, WHO, EU GMP Practices in Pharmaceutical industry & faced Regulatory Audits ANVISA Audit, CFDA Audit.

Dy. Manager – Engineering Projects at Standard Group of company (S2 ENGINEERING Projects) (2025-05 – Present)

• Project planning and material estimation.
• Project Execution.
• Project Scheduling.
• Handling Turnkey Projects handling
• In S2 Engineering successfully completed three projects in hand’s (Anuh pharma Limited, BDR Life sciences Pvt.Ltd MacLeods pharma.)

Dy. Manager – Engineering Maintenance and Projects at Vital Laboratories Pvt. Ltd. (2024-11 – 2025-05)

• Plant Reactors total capacity 416KL.
• No. of Clean Rooms 17 No’s
• Three solvent recovery systems 08 No’s.
• 5 Ton Boiler, 6 Ton Boiler & Hot Oil Systems 3no.s available (2L Kcal/hr., 1L Kcal/hr., 2L Kcal/hr.).
• Project planning and material estimation.
• Material follow-up.
• Project schedule planning.
• Identifying and evaluating the maintenance needs of the process equipment.
• Preparation / Execution of qualification & validations related to Process Equipment’s, Water systems & HVAC System.
• Preventive and Breakdown maintenance of Process Equipment’s, Utility Systems, Water Systems & HVAC.
• To ensure proper operations of Utility, RO, EDI Water systems & HVAC System.
• Ensure Preventive maintenance activities, cleaning schedules and documentation pertaining to maintenance practices.
• All Documentation & Physical Activities are preforming as per cGMP, EU GMP, WHO, US FDA Guidelines.
• Preparing of PM schedule, checklists & Checklist records, History cards & filling the same w.r.t. Audit requirement in coordination with production, Warehouse & QA dept.
• We are Handled Regulatory Audits & Costmary Audits (cGMP, WHO, ANVISA Brazilian Regulatory Audit & CFDA Audit Also Faced.
• Maintenance of utility equipment’s & Process Equipment’s, like Chilling plants, Air compressors, Nitrogen plant, air dryers, cooling towers, blowers, VTD, RCVD, ANFD’s, FBD, Micronizers, heat exchangers, Air handling unit, vacuum pumps, Purified water Plant, RO Plant, Softening plant, Boiler etc.
• Preparation of Qualifications & Validation protocols for equipment’s, URS, TRS, DQ, FAT, SAT, IQ, OQ & PQ.
• Designing, planning, Installation and validating the clean room facilities for API facilities.
• Nitrogen and Air Qualification & Validations as per ISO 8573 Standards.
• Temperature mapping as per WHO Technical Report Series, No. 961. Guidelines.
• To prepare engineering SOP’s & Qualification of Process equipment’s.
• Conducting on Job Trainings.

Asst. Manager - Projects and Maintenance at Angels Pharma India Private Limited ( TAGOOR GROUP) (2017-03 – 2024-11)

• Plant Reactors total capacity 526KL.
• NO of Reactors total 102 no’s (GLR's-30no.s, SSR's-72no.s).
• Three solvent recovery systems are erected.
• Project planning and material estimation.
• Material follow-up.
• Project schedule planning.
• Identifying and evaluating the maintenance needs of the process equipment.
• Preparation / Execution of qualification & validations related to Process Equipment’s, Water systems & HVAC System.
• To ensure proper operations of Utility, RO, EDI Water systems & HVAC System.
• Ensure Preventive maintenance activities, cleaning schedules and documentation pertaining to maintenance practices.
• All Documentation & Physical Activities are preforming as per cGMP, EU GMP, WHO, US FDA Guidelines.
• Preparing of PM schedule, checklists & Checklist records, History cards & filling the same w.r.t. Audit requirement in coordination with production, Warehouse & QA dept.
• We are Handled Regulatory Audits & Costmary Audits (cGMP, WHO, EUGMP, Mylan Global Audit, HETERO, SUN Pharma, Dr. Reddy’s, NATCO, SOLARA Active Pharma, Biocon, Piramal Pharma, ….,
• Maintenance of utility equipment’s & Process Equipment’s, like Chilling plants, Air compressors, Nitrogen plant, air dryers, cooling towers, blowers, VTD, RCVD, ANFD’s, FBD, Micronizers, heat exchangers, Air handling unit, vacuum pumps, Purified water Plant, RO Plant, Softening plant, Boiler etc.
• Preparation of Qualifications & Validation protocols for equipment’s, URS, TRS, DQ, FAT, SAT, IQ, OQ & PQ.
• Designing, planning, installation and validating the clean room facilities for API facilities.
• Nitrogen and Air Qualification & Validations.
• To prepare engineering SOP’s & Qualification of Process equipment’s.
• Conducting on Job Trainings.

Project Engineer at Vertex Air Technology Pvt. LTD. (2013-09 – 2017-03)

HVAC PROJECTS HANDLED

• Hetero /Honour Labs labs — Sep 2013 to Feb 2015 — Site Engineer
• Smilax Laboratories Pvt. LTD. — Apr 2015 to Jun 2016 — Site Engineer
• VIRCHOW Drugs — March 2015 to Feb 2017 — Site Engineer
• Metrochem Pvt. LTD. — Jun 2016 to Feb 2017 — Site Engineer
• Sionc Pharma Pvt. LTD. — Jun 2016 to March 2017 — Site Engineer
• Dr. Reddy’s CTO-6 — Aug 2016 to Nov 2016 — Site Engineer
• Reading and Studying Drawings, Blueprints, Piping, and instruments Diagrams.
• Implement cost effective measures for reducing project cost.
• Technical meetings with consultant/client/contractor and weekly progress meetings with the client.
• Coordinates with construction management team for readiness of the buildings for installation of HVAC equipment & ducts.
• Scheduled the project and reviewed weekly to ensure that the project timeline maintain.
• Execution & Commission the AHU capacities Up to 60000CFM (10 TR to 300 TR) water cooled & air-cooled (DX-coils) & installation of all parts in the AHU like a blower, FLP motors, Pulley alignment, A & B-Belts are sizes, Cooling coil & dehumidifier coil installation, Pre & Fine-filters (20, 10, 5 micron) canvas connections & Fresh air, supply air & Return air Volume dampers & AHU pressure gauges at return air.
• Installation of VAV, CAV, Sequential controller panels and actuators fixing with control panel for fire and control dampers and installation of smoke spill fans for fire exit and VRF units with an indoor unit etc.
• Installation of recirculation & once through AHU’s units (DX-Systems, Ventilation & Exhaust units of specified rated capacities.
• Proper checking of AHU -VCD’s connections (Supply, Return & Fresh Air), motor & blower direction, alignment, power supply, Proper insulation and sealant for duct gaps & Cleanness before handing over to the client.
• Preparation of Validation HVAC Qualifications DQ, IQ & OQ.
• Conducting of Air velocity, HEPA Filter integrity test, Pressure Differential, Particle count, Particle recovery, Air flow pattern test & Temp & Humidity test as per ISO 14644 Guidelines.

Diploma Trainee at DELPHI-TVS TECHNOLOGIES Ltd. (2012-07 – 2013-07)

• Heat Treatment plant maintenance works and Operating Thermal de-burring, SQF, FBF & STP machines.

Diploma in Mechanical Engineering – S.V.GOVT.POLYTECHNIC College TIRUPATHI, State Board of Technical Education (2012)