AutoCAD
KARTHIK M
Engineering & Projects
Hosur
Summary
Pharmaceutical Engineering professional with 7+ years of experience in equipment installation, qualification, CAPEX projects, utilities, HVAC, and GMP-compliant maintenance in USFDA/MHRA-regulated facilities. Proven expertise in preventive/predictive maintenance, regulatory audit readiness, vendor management, and cross-functional project execution with focus on efficiency, compliance, and timely delivery.
Overview
8
8
years of professional experience
2
2
Certifications
3
3
Languages
Work History
Senior Executive – Engineering
ORBION Pharmaceuticals
06.2023 - Current
- Led the installation, qualification, and commissioning of critical process equipment, including RMGs, FBDs, blenders, Mespack H-170D, 150BPM liquid line, 3000L Twin column OCG blender, ACG auto coater SC700XOne, and HVAC systems.
- Led the mechanical maintenance team to ensure uninterrupted operation of process equipment by implementing preventive maintenance strategies, managing critical spare parts inventory, and promptly addressing breakdowns to minimize downtime, and enhance overall productivity.
- Planned and executed multiple CAPEX projects end-to-end (budgeting, vendor coordination, PR/PO, FAT, installation, and qualification).
- Delivered a compact Liquid Manufacturing Line (URS to PQ) within a small facility footprint, ensuring compliance, and timely completion.
- Directed Module Bifurcation Project – full plant modification (civil, AHU, utilities) within four days, minimizing production downtime.
- Implemented preventive and predictive maintenance schedules to reduce equipment downtime.
- Coordinated with QA for regulatory audits (USFDA, MHRA), and ensured GDP-compliant documentation.
- Handled vendor management, PR/PO approvals, procurement follow-ups, and SAP workflows.
- Enhanced project efficiency by implementing advanced engineering solutions and streamlining processes.
Executive – Engineering
MICRO LABS
11.2020 - 05.2023
- Prepared and executed preventive maintenance schedules for granulation, compression, capsule filling, coating, and packing equipment.
- Ensured audit readiness and compliance with MHRA/US FDA through accurate documentation and validation.
- Drafted SOPs, supported equipment qualification, and executed HVAC validation activities.
- Participated in the installation, utility connections, and decommissioning of obsolete equipment.
- Performed breakdown analysis and predictive maintenance to improve reliability and reduce downtime.
- Conducted thorough risk assessments for each project phase, mitigating potential hazards before they became costly setbacks or delays.
- Implemented safety protocols that contributed significantly towards zero workplace accidents during tenure as an executive engineer.
- Reduced maintenance costs with proactive identification of potential issues and implementation of preventive measures.
Junior Engineer – Engineering
BONN SCHERING (Confidential)
10.2018 - 11.2020
- Supported preventive and breakdown maintenance of OSD process equipment and utilities.
- Assisted senior engineers in equipment qualification, audit preparation, and documentation.
- Developed technical expertise in HVAC, utilities, and spare inventory handling.
Trainee – Engineering
SWISS GARNIER (Confidential)
08.2017 - 08.2018
- Learned fundamentals of process equipment maintenance in a regulated pharma setup.
- Assisted engineering team with documentation, preventive schedules, and inspections.
Education
B.E. - Mechanical Engineering
Karpagam Institute of Technology
01.2017
Higher Secondary - undefined
St. Joseph Matriculation Higher Secondary School
01.2013
SSLC - undefined
Guru Dhronacharya School of Excellence
01.2011
Skills
- Granulation: HSG (Glatt), RMG (Sainath, Ganson), FBP (Glatt, ACG), Sifter (Sweco, Russell)
- Compression: ACG Legacy 6100, Sejong (HRC51, MRC27, HRC49)
- Capsule Filling: ACG (AF90T, ZRO90T, ZRO200T, ACURA 100FF)
Machinery handled
- Coating/Inspection: Neocota, Glatt, ACG
- Packing Lines: BQS, BMAX, Mespack, Strip Packing, CVC Bulk Line
- Secondary Packing: Hi-Cart, Vector Auto Cartonator
SKILLS AutoCAD Data science and Analytics Equipment Qualification GMP Compliance HVAC Systems Predictive/Preventive Maintenance SAP SolidWorks SOP Documentation
Software
Solid works
Tableau
MS excel
MS word
Certification
AutoCAD
Timeline
Senior Executive – Engineering
ORBION Pharmaceuticals
06.2023 - Current
Tableau
04-2023
Executive – Engineering
MICRO LABS
11.2020 - 05.2023
Junior Engineer – Engineering
BONN SCHERING (Confidential)
10.2018 - 11.2020
Trainee – Engineering
SWISS GARNIER (Confidential)
08.2017 - 08.2018
AutoCAD
05-2017
Higher Secondary - undefined
St. Joseph Matriculation Higher Secondary School
SSLC - undefined
Guru Dhronacharya School of Excellence
B.E. - Mechanical Engineering
Karpagam Institute of Technology
Similar Profiles
Krishnaveni SundarrajanKrishnaveni Sundarrajan
Research Associate (E5) Analytical Development at OrBion Pharmaceuticals Private LimitedResearch Associate (E5) Analytical Development at OrBion Pharmaceuticals Private Limited
Elanchselvam SElanchselvam S
Sr.Executive at M/s “EVERGREEN Pharmaceuticals Private limited”Sr.Executive at M/s “EVERGREEN Pharmaceuticals Private limited”
KASIA WAJERKASIA WAJER
Senior Global Project Manager at Jazz Pharmaceuticals/ GW PharmaceuticalsSenior Global Project Manager at Jazz Pharmaceuticals/ GW Pharmaceuticals
AKASH SAKASH S
Project Intern at Ashok Leyland, Hinduja Group Ltd.Project Intern at Ashok Leyland, Hinduja Group Ltd.
Rachel PriyankaRachel Priyanka
ServiceNow Developer at CGIServiceNow Developer at CGI