AHMED QUADRI HMG
Mechanical Engineer
Dammam
Summary
A Versatile Engineer offering quality assurance, root cause analysis and project management expertise coupled with outstanding multitasking and communication abilities. Polished in observing and monitoring project milestones and interacting with clients to interpret needs. Sound knowledge of design and visualization software.
Breadth of experience in Manufacturing, and R&D has enabled achieving project objectives through managing relationships within cross-functional teams and effective issue resolution.
Leader for quality management systems with in the areas of CAPA's, Change Control, Document Control, and Compliance, working under FDA Consent Decree and Quality Management Systems Remediation Projects.
Skilled in conceptualizing, designing, and implementing innovative solutions ensuring operational efficiency and regulatory compliance.
Expertise includes mechanical system design, implementation, & commissioning adhering to standards and enhancing energy efficiency.
Proficient in pharmaceutical/biotechnology facility design and validation, adhering to rigorous regulatory standards. Committed to driving technological advancement and efficiency in collaborative environments, delivering impactful solutions that exceed expectations.
Overview
5
5
years of professional experience
Work History
Senior Consultant
Amneal Pharmaceuticals
Brookhaven
05.2022 - 09.2024
- Spearheaded procurement and implementation efforts for new equipment and technologies, ensuring alignment with regulatory standards such as cGMP
- Conducted thorough evaluations of equipment vendors and assessed technical specifications to modernize the manufacturing facility
- Prepared Strategic Target Proposal (STP), Capital Appreciation Report (CAR), Return on Investment (ROI), Purchase Request (PR) and Purchase Orders (PO) to accommodate new and existing project requirement and smooth flow
- Collaborated with cross-functional teams to identify opportunities for cost reduction and efficiency enhancement
- Utilized data analysis and process optimization techniques to streamline workflows, minimize waste, and maximize resource utilization, fostering a culture of continuous improvement
- Prepared, developed, and reviewed Validation Protocols & Standard Operational Protocols for a wide range of manufacturing and facility equipment
- Classified equipment based on the extent of qualification required and conducted thorough testing against FDA and organizational standards to maintain equipment in qualified state
- Classified manufacturing equipment based on PLC, IPC, and HMI capabilities to determine qualification requirements according to 21 CFR PART 11
- Designed and prepared CSQ protocols to test security, audit trail integrity, and batch record competence
- Mapped storage facility and warehouse storing final products and raw materials to monitor temperature and relative humidity data adhering to company policies and FDA standards
- Developed cleaning validation procedures to ensure effective and consistent cleaning processes with acceptable residue levels
- Contained production related quality events and unplanned deviations by 25% through rigorous troubleshooting, In-depth investigations on UD's, cleaning/quality related issues and proposed effective strategies which significantly improved coating, mixing, and granulation processes and reduced production downtime
- Collaborated with cross-functional teams to develop corrective actions and preventive actions, ensuring performance and quality of production equipment by optimizing Operation and Maintenance procedures
- Implemented strategies within the production plant to enhance production quality and compliance, aligning with industry standards
- Enhanced time efficiency by 25% in quality management and quality control activities by integrating production equipment to a central server for remote batch record remote accessibility and monitoring
- Managed Master Qualification Program and Preventive Maintenance Schedule for production equipment throughout their lifecycle, ensuring compliance with company and FDA constraints
- Accumulated and implemented appropriate procedures to store and manage User Access database
HVAC Engineer
Balancing Services Incorporated
Queens
08.2021 - 04.2022
- Validated and commissioned mechanical HVAC and hydronic systems to ensure designed output is attained in alignment to NEBB and ASHRAE standards to make space habitable for occupants
- Enhanced the operation and maintenance schedule of building equipment to accomplish maximum efficiency with optimal energy consumption prolonging life cycle of the AHU's, DOAS, Economizers, RTU's, GTL'S, Pumps, Dust Collectors, Chiller's, and Boiler
- Coordinated & corresponded with project heads to address and mitigate onsite progress, ETA, and challenges respectively
- Prepared and Documentation PPR's with analyzed data and refined technical information enabling non-technical audience to understand project status and progress
Research Engineer
Bio-Nanotechnology and Bio-Material Lab
Old Westbury, NY
01.2020 - 07.2021
- Researched & developed an optical Bio-MEMS device to detect the nano structured virus at early state using a porous silica chip with nanopore ranging from 60-120 Nm and depth of 80 Nm
- Computed Mechanical & Biological characteristics of a sensor which resulted in attaining 60-70% of sensor durability and repeatability
- Accelerated detection of nano scaled Human Immunodeficiency Virus eliminating the need of trained technicians and expensive storage equipment of diagnostic centers
- Functionalized nanoporous silica wafer surface creating a habitable environment to capture target virus protein
- Generated and reviewed reflection spectral graphs and diagnose the captured virus proteins on porous silica microchip
- Collaborated with Brook Haven National Laboratory to work on capturing the nano structure network formed on the silica wafers using scanning electron microscope
- Successfully tested and captured target virus protein(s) on the artificially functionalized nano porous silica surface with interferometric spectroscopy principles
- Presented and Defended research findings against panel of reputed researcher
Education
Master of Science - Mechanical Engineering
New York Institute of Technology - College of Engineering and Computer Science
New YorkBachelor of Technology - Mechanical Engineering, Business Management
Vignan University - College of Mechanical Engineering
Guntur, IndiaSkills
- PMP
- OSHA 10
- OSHA 30
- SST
- Sigma Six White Belt
- Quality Control
- Root Cause Analysis
- DFME
- Critical Process Monitoring
- MEP drafting/design
Certifications:
Major Skills:
Product Lifecycle Management
- Quality Management Systems
- FDA regulations 21 CFR PART 10, 11, 820
- GMP compliance
- Validation Protocols
- Computer System Validation
- Basic PLC integration and programming
- PID loop
- Val Genesis
- Blue Mountain
- MS Office
- Matlab
- Minitab
Applications:
Projects
Go-Kart Design and Fabrication, Solid works, Ansys, Creo, Designed & built a standard Go Kart 3D model in solid works with 98% acceptable Factor of Safety.
Languages
English
First Language
Hindi
Advanced (C1)
C1
Urdu
Advanced (C1)
C1
Telugu
Upper Intermediate (B2)
B2
Arabic
Elementary (A2)
A2
Timeline
Senior Consultant
Amneal Pharmaceuticals
05.2022 - 09.2024
HVAC Engineer
Balancing Services Incorporated
08.2021 - 04.2022
Research Engineer
Bio-Nanotechnology and Bio-Material Lab
01.2020 - 07.2021
Master of Science - Mechanical Engineering
New York Institute of Technology - College of Engineering and Computer Science
Bachelor of Technology - Mechanical Engineering, Business Management
Vignan University - College of Mechanical Engineering
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