Meet Acharya
Victoria
Summary
Graduate Industrial Engineer and certified with professional and hands on over 5+ years of co-op experience. Experienced Industrial engineer well versed in the domain of facility designing, lean tools, Value stream Mapping, logistics & Material flow, Continuous Improvement, Time study, Cost reduction and production process flow. Result-driven Mechanical Maintenance Engineer working in Petrochemical Industry with experience in preventive, predictive, and corrective maintenance of industrial equipment. Proven ability to troubleshoot mechanical system, reduce downtime, and improve plant reliability through root cause analysis and continuous improvement initiatives. Strong background in maintenance planning, equipment inspections, and compliance with safety and operational standards. Pharmaceutical experience, including Equipment Validation, CSV, Process Validation, qualification of manufacturing and facilities. Experience in the development and execution of installation, operational, and performance qualification protocols (IQ/OQ/PQ) in accordance with 21CFR 210 and 211 with an emphasis on process equipment qualification: compounding, filling, inspection and packaging of vials, ampoules and pre-filled syringes. Demonstrated Quality tools/methodologies including: SPC, DOE, GR&R, FMEA, CAPA, complaint investigation, process validation and FDA standards.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Mechanical Engineer, Testenger
Formosa Plastics
Point Comfort, Texas, USA
01.2023 - Current
- Ensure compliance with industry standards (ASME, API, OSHA) and regulatory requirements.
- Develop detailed engineering drawings, P&IDs, and other technical documentation after each management of changes (MOCs).
- Engineering and Design: Participate in the design and engineering of new equipment and modifications to existing systems.
- Maintenance and Repair: Plan and execute preventive maintenance programs to optimize equipment reliability. Support Maintenance crew for the scheduled plant turnaround.
- Troubleshoot and diagnose equipment failures to identify root cause and implement corrective actions.
- Execute B-1 Projects for Mechanical Maintenance. Prepare bid package and purchasing requisition for B-1 Projects and control project expenses within budget. Prepare B-2 Project cost estimate. Produce engineering drawing for bid, reference, or review drawing and evaluate vendor quotation and contractor bids. Ensure materials and or services are paid timely and correctly processed.
- Provide maintenance performance and support by communicating and working with operations to establish equipment criticality and provide standby equipment for critical equipment. Apply data analysis techniques to develop engineering solutions to repetitive failures and other problems that adversely affect plant operations including safety, environmental, capacity, quality, cost, and regulatory compliance issues. Historical files shall be established and well-maintained to allow for correct diagnoses of equipment failures and performance of equipment maintenance.
- Implement company safety policies and procedures, using employee training, work planning, audits and other tools to ensure compliance with safety regulations and progress toward achieving the goal of zero incidents. Maintain equipment in such manner as to eliminate environmental emissions, upsets, or unscheduled shutdowns which will result in zero non-conformances and zero emissions or releases.
- Provide daily unit status reports to management. Comply with EH&S internal/corporate audits and respond to audit findings. Implement/educate/train and adhere to all company policies and procedures.
- Work with Operations/Maintenance to develop and maintain mechanical manual to set up and ensure critical spare parts for the equipment maintenance.
Validation Engineer
Vastek Inc
Albany, NY, USA
05.2020 - 01.2023
- Managed validation documentation and execution for IQ, OQ, and PQ protocols for pharmaceutical manufacturing and laboratory equipment.
- Performed temperature mapping of controlled temperature units including refrigerators, freezers, vaults, and incubators using Kaye Validator systems.
- Executed cleaning validation studies for compounding tanks, part washers, and lyophilizers in compliance with GMP standards.
- Led equipment qualification activities for manufacturing systems including vial washers, fillers, mixers, and capping machines.
- Developed User Requirement Specifications (URS) and Functional Design Specifications (FDS) in collaboration with engineering and end users.
- Qualified critical utility systems including HVAC, steam, WFI, compressed air, and purified water systems for sterile manufacturing operations.
- Conducted risk assessments to classify systems as Direct Impact, Indirect Impact, or No Impact on product quality.
- Coordinated with vendors and engineering teams for Factory Acceptance Tests (FAT) and validation planning aligned with Quality by Design (QBD) principles.
- Supported process qualification and media fill simulations for vial and syringe filling lines.
- Investigated deviations, exceptions, and performed root cause analysis to maintain compliance with regulatory requirements.
- Participated in cross-functional validation teams to ensure adherence to FDA, EU GMP, and international regulatory standards.
Manufacturing Engineer
Murlidhar Die & Tools
India
01.2017 - 05.2018
- Best practice in Solid command of technologies, tools and best practices in 3D part model designing using SolidWorks (2D-3D), AutoCAD engineering drawings. Proficiencies in reading blueprints/drawings.
- Introduce JIT to reduce the waste of WIP inventory by 15%.
- Manages New Product Development Process (NPDP), Robust plant and schedule, BOMs, Perform PFMEA.
- Identified suitable materials for production use that aligned with environmental concerns and budget constraints.
- Created parts for various fabrication methods, including machining, sheet metal fabrication and injection molding.
- Developed Machining operations and techniques. Plunged manufacturing cost and time using Lean manufacturing. Accelerate production rate of Aluminum part by 25%. Decrease machining time by 1.25 min per product.
- Create work instructions and standardize process to minimize accident and take safety trainings and initiate TPM.
- Changed materials and finishes throughout product line to improve performance and reduce corrosion.
- Tested the feasibility, design, operation and performance of equipment, components and systems.
- Performed concurrent design and manufacturing engineering and other functions to reduce time required to bring product to market.
Education
Master of Science - Industrial Engineering
Lamar University
Texas, USA05-2020
Bachelor of Science - Mechanical Engineering
Gujarat Technological University
India01-2017
Skills
- AutoCAD, SolidWorks from IGTR
- R essential, Python for Data Science, Python for Data Analysis from IBM
- Applications: MS Project, MS Visio, MS Excel (VBA), MS Word, MS Power Point
- Database: MY SQL, MS Access, SAP- RDBMS
- Data Analysis and Statics: R, Python
- Automation and Design: AUTOCAD, SolidWorks
- Effective communication
- Equipment qualification
- Testing protocols
- CAPA management
- ERP Systems: SAP-ERP, MRP
Certification
- AutoCAD, SolidWorks from IGTR
- R essential, Python for Data Science, Python for Data Analysis from IBM.
Timeline
Mechanical Engineer, Testenger
Formosa Plastics
01.2023 - Current
Validation Engineer
Vastek Inc
05.2020 - 01.2023
Manufacturing Engineer
Murlidhar Die & Tools
01.2017 - 05.2018
Master of Science - Industrial Engineering
Lamar University
Bachelor of Science - Mechanical Engineering
Gujarat Technological University