KAILAS SONAWANE
Nashik
Summary
Mechanical Engineer with more than 10 years of experience in the pharmaceutical API industry. Currently working as Sr. Executive – Engineering at Olon API India Pvt. Ltd. Responsible for projects and maintenance, equipment qualification, validation, and compliance activities.
Overview
11
11
years of professional experience
1
1
Certification
3
3
Languages
Work History
Sr. Executive - Engineering
Olon API India Pvt. Ltd. (Formerly Known as Sandoz)
Mahad, Raigad
01.2021 - Current
- Looking after projects and maintenance activities in the plant to ensure smooth and safe operation.
- Executing and coordinating qualification and validation of equipment, HVAC, nitrogen, and utility systems with QA and validation teams.
- Handling CAPEX projects like high potent isolator facility, 100 KL fermenter installation, new reactors, blenders, and other modifications.
- Preparing and reviewing SOPs, deviations, and change requests (CRs) related to engineering.
- Managing preventive and breakdown maintenance through SAP PM module and tracking equipment performance.
- Preparing monthly CAPEX and maintenance MIS reports and conducting annual breakdown reviews.
- Ensuring all work follows GMP, safety, and statutory requirements.
- Supporting IMS audits as per ISO 14001 (Environment) and ISO 45001 (Health & Safety) standards.
- Preparing and maintaining engineering documents for GMP, IMS, and client regulatory audits.
- Reviewing P&IDs, layouts, and equipment drawings during project execution.
- Managing procurement and inventory through SAP MM module and coordinating with vendors
- Duties and Responsibility
Executive - Engineering
Olon API India Pvt. Ltd. (Formerly Known as Sandoz)
Mahad, Raigad
01.2019 - 01.2021
- Utilities operations and maintenance like Ammonia based refrigeration plant (200TR X 5), Boiler(12TPH X 2), ETP, water treatment plant, HVAC, Cooling towers, Thermic fluid (200RT X 4) system and Compressed air (Nitrogen and Process air) system.
- Erection, commissioning and startup of Capital projects / Plant modification jobs.
- Utility/HVAC Operations & Maintenance budget preparation, monitoring & control, expense record & downtime analysis.
- Daily and monthly MIS Preparation.
- Review daily Operational Checklist and Log books.
- Responsible to carry out all qualification & validation activities including (clean room area, nitrogen air and equipment).
- Responsible for Boiler and Economizer IBR approval activities.
- Review SAP PM Work orders.
- Material procurement in SAP module.
- Safety & Statutory compliance
- Duties and Responsibility
Engineering Executive
Novartis (Formerly Known as Sandoz)
Mahad, Raigad
08.2017 - 01.2019
- Implement cGMP and Safety practices related to engineering as per Novartis Guidelines.
- To undergo assigned trainings on cGMP, HSE & departmental procedures/policies & train subordinates on these topics (as & when required).
- Responsible to carry equipment preventive and SAMACO maintenance as per schedule.
- Responsible to correct breakdowns at lowest nonproductive time.
- To perform safe maintenance jobs ensuring proper usage of PPEs, SCBA (as & when required).
- Participate in safety training programs. Coordination with safety department for safe execution of jobs, HIRA, Aspect-Impact initiation activities.
- Compliances for GMP audit points.
- Track change controls, quality events, deviations, safety audit/walkthrough points and closer for the same.
- Equipment/system qualification.
- Responsible for execution of training activities in the engineering dept.
- Generation and maintenance of the documentation of assigned equipment, systems, standards and operating procedures.
- Prepare monthly report of engineering dept.
- To do ERP/SRM activities.
- To generate all plant P&IDs and FDA floor layouts.
- Duties and Responsibility
Maintenance Officer
Embio Limited.
Mahad, Raigad
05.2016 - 08.2017
- Daily equipment log book checking. Meeting with production department regarding maintenance planning review.
- Issuing daily various permits-General, hot, height, excavation, vessel entry/confined space entry etc. after over all checking safety point on location.
- Planning major job maintenance activity. Planning daily preventive maintenance. Daily plant equipment checking for visual inspection. Planning of man power as per planning schedule.
- Maintain availability of minimum spare & continue flow of spare part. Checking bought out material by purchase department. Local purchase.
- Prepare maintenance MIS report with PPT (highlights).
- Audit awareness program to departmental employee
- To see the daily job allocation to fitters and contractors.
- To carryout daily Planned preventive maintenance and breakdown maintenance as per schedule.
- Responsible for GMP documentation relating to maintenance dept.
- Follow the safety and factory guidelines.
- To maintain maintenance consumable spare parts.
- Duties and Responsibility
- Reporting to- Deputy manager, Maintenance
Sandoz Technical Trainee
Sandoz Pvt. Ltd.
Mahad, Raigad
03.2015 - 03.2016
- Current CTC: - 10.5 LPA
- Expected: - 15.0 LPA
Education
Bachelor of Engineering - Mechanical
NDMVP’s College of Engineering
Nashik01.2014
Diploma in Mechanical Engineering - undefined
K.K. Wagh Polytechnic
Nashik01.2011
SSC - undefined
Mahatma Phule High School
Dugaon01.2008
Skills
CAPEX project & maintenance management
Equipment validation
HVAC/ Utility systems
GMP compliance
SOP preparation
QMS
SAP PM module
Procurement management
ISO 14001 & 45001 compliance
Facility management
DECLARATION
I hereby declare that the above written particulars are true to the best of my knowledge and belief. Date : Place : Mahad SONAWANE KAILAS RAGHUNATH
Certification
Elementary & Intermediate grade
Timeline
Sr. Executive - Engineering
Olon API India Pvt. Ltd. (Formerly Known as Sandoz)
01.2021 - Current
Executive - Engineering
Olon API India Pvt. Ltd. (Formerly Known as Sandoz)
01.2019 - 01.2021
Engineering Executive
Novartis (Formerly Known as Sandoz)
08.2017 - 01.2019
Maintenance Officer
Embio Limited.
05.2016 - 08.2017
Sandoz Technical Trainee
Sandoz Pvt. Ltd.
03.2015 - 03.2016
Diploma in Mechanical Engineering - undefined
K.K. Wagh Polytechnic
SSC - undefined
Mahatma Phule High School
Bachelor of Engineering - Mechanical
NDMVP’s College of Engineering