SANDEEPKUMAR C - Mechanical Engineer

MOBILE: 882-***-****

Email : ad072h@r.postjobfree.com

Objective:

Dedicated Mechanical Engineer with a strong background in troubleshooting, root cause analysis, and a proven track record in HVAC, water systems, and pharmaceutical facilities. Seeking a challenging role in the pharmaceutical industry to apply my expertise in ensuring the reliability, efficiency, and compliance of critical systems, along with overseeing maintenance and managing engineering projects. Professional Experience:

1.Pharmaceutical Facility Engineer

•Expertly conducted troubleshooting and root cause analysis for HVAC systems, resolving complex issues efficiently.

•Supervised the Building Management System (BMS) plant, ensuring optimal performance, monitoring, and troubleshooting.

•Oversaw the qualification of HVAC systems, including air balancing, ACPH calculations, and differential pressure setting activities.

•Managed clean room qualification and qualification of classified cold rooms, adhering to pharmaceutical industry standards.

•Led troubleshooting efforts and root cause analysis for water system plants, ensuring uninterrupted operation.

•Specialized in dosing preparation, calculations, and maintenance of Purified Water Generation

(PWG), Purified Water Storage and Distribution (PWSD&WFIG), and Water for Injection (WFI) systems 2.Process Equipment Engineer

•Spearheaded performance qualification and temperature mapping activities for critical process equipment, such as fermenters and blending vessels.

•Demonstrated expertise in troubleshooting process equipment, including autoclave (DAT, SAT, and DHS) issues.

•Monitored preventive maintenance and breakdown maintenance for pharmaceutical equipment, ensuring minimal downtime.

•Managed Class ‘A’ equipment, CIP stations, and production fermenters, implementing CAPA and risk assessment/mitigation strategies.

3.Project Engineer

•Led evaluation and implementation of minor and major engineering projects, ensuring compliance with development plans.

•Collaborated with cross-functional teams to successfully execute engineering projects while meeting quality and timeline requirements.

4.Validation Technician

•Led the development and execution of validation protocols for pharmaceutical manufacturing equipment and processes, including IQ, OQ, and PQ activities.

•Collaborated with cross-functional teams to ensure adherence to cGMP (current Good Manufacturing Practices) and regulatory requirements.

•Designed and implemented validation strategies for new product launches and equipment installations, meeting project timelines and quality standards.

•Conducted risk assessments and mitigation plans to address potential validation issues, ensuring product quality and patient safety.

•Managed the documentation and change control processes related to validation, maintaining comprehensive records of validation activities.

•Performed equipment qualifications, calibration, and maintenance to ensure accurate and reliable pharmaceutical processes.

•Conducted process validations, cleaning validations, and sterilization validations, ensuring product quality and regulatory compliance.

•Supported investigations into deviations and non-conformities, identifying root causes and implementing corrective and preventive actions (CAPA).

•Developed and maintained validation master plans, ensuring a standardized approach to validation across the organization.

•Collaborated with regulatory affairs to address inquiries and submissions related to validation activities during inspections.

•Maintained and calibrated instrumentation and equipment used in validation activities.

•Assisted in generating validation reports and summarizing results, contributing to the validation documentation and reporting process.

•Supported the validation team in data collection and analysis, as well as validation-related investigations.

•Executed validation protocols for pharmaceutical equipment, utilities, and processes, adhering to established procedures.

Skills:

• HVAC Troubleshooting

• BMS Operation and Supervision

• Clean Room Qualification

• Water System Analysis

• Pharmaceutical Equipment Maintenance

• Process Equipment Troubleshooting

• Project Management

• Risk Assessment and Mitigation

• Compliance with Pharmaceutical Standards

• Dosing Preparation and Calculations

• Equipment Validation

• Process Validation

• IQ, OQ, PQ Protocols

• cGMP and Regulatory Compliance

• Risk Assessment and Mitigation

• Change Control

• Calibration and Maintenance

• Root Cause Analysis and CAPA

• Validation Master Plans

• Documentation and Reporting.

Education:

• Bachelor of Engineering (B.E) with 7.3 CGPA from KPR INSTITUTE OF ENGINEERING AND TECHNOLOGY .

• Secondary School with 78% from SHRI RENGA VIDYALAYA HR SEC SCHOOL.

• High School with 74% from SRI GIRI EASWARA MATRIC SCHOOL. Certifications:

• Air handling unit (DCVMN).

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