MSEE
International Accreditation
Connect science, technologies, the most advanced engineering approach to infuse projects with novel ideas while outperformong the requirements to provide over the expectations.
Dan Craciun
North Carolina, USA
Regulatory:
Adept in navigating FDA (21 CFR Part 210/211, Part 820, Part 4, Part 11) and EU (Annex 11) regulations, cGMP, GAMP, and ISO-IEC standards to ensure project compliance and product quality
Quality Assurance Expertise:
Provide quality support for acceptance, commissioning/qualification, and process validation, ensuring adherence to industry best practices and regulatory requirements
Drive the development and implementation of robust Quality Management Systems (QMS) to ensure ongoing compliance and operational excellence
Compliance through C&Q & V&V: Leveraging my expertise in Configuration Management (C&Q) and Verification & Validation (V&V), I ensure systems meet all regulatory requirements and function as intended.
Engineering Proficiency:
Skilled in design, commissioning, and maintenance of production systems, facilitating efficient operations and maximizing uptime
Interdisciplinary Collaboration:
Possess a multidisciplinary background encompassing electrical engineering, controls, automation, IT, robotics, and project management, fostering seamless collaboration across teams
Enhanced Manufacturing with Design & Integration:
By optimizing equipment design, integrating critical systems, and implementing process improvements, I contribute to smoother, more efficient manufacturing operations
Streamlined Project Management:
Project management methodologies to ensure successful project execution, on-time delivery, and adherence to budget constraints
Embracing Competence, Professionalism and Work ethics, the PATH to EXCELLENCE!
Professional Approach
Understand and envision patient needs…
Connect the science and the technologies using the most advanced engineering approach to enhance projects
Generate novel ideas to outperform requirements and provide over the expectations
KAIZEN
TOYOTA PRODUCTION SYSTEM (TPS)
JUST IN TIME (JIT)
AREAS OF EXPERTISE
Services
Quality Systems
● Implementation and Alignment
▪ Policies
▪ Procedures
▪ Protocols
Commissioning, Qualification, Validation
● Specification traceability
● FAT, SAT
● Protocol Authoring, Reports, Summaries
● SOP's, Handover
Quality
● Risk Management ● Compliance assessment
● Gap analysis and remediation ● Audit
● Policies, Procedures, Protocols
GxP
● CSV, Equipment, Utilities, BMS
● Electronic Documents, UID / GUDID
● Packaging Lines
● Filling Lines
● SIP/CIP
Engineering
● Performance and optimization
● Solution implementation
● Installation, integration, training, post-installation and manufacturing support
Curriculum
Education
Master of Science in Electrical Engineering - Milwaukee Council of International Education
MSEE
Industrial Automation, Communications
Master of Science in Electrical Engineering
BSEE
Industrial Automation
Bachelor of Science in Electrical Engineering
Continue Education
ROBOTICS
FANUC Robotics
IT
Software Development
HTML and CSS, W3Schools
PC Computers, mainframe, networking, data communication, OS
WINDOWS, LINUX
STATISTICS
Acceptance Sampling - Taylor
Engineering Statistics
Certifications and Training
COMPLIANCE
GMP & cGMP
GAMP 5
Commissioning and Qualification, ISPE
Risk-Based Commissioning & Qualification Benchmarking, ISPE
21 CFR Part 11 / ANNEX 11, Data Integrity
Software Validation
Process Validation
REGULATORY
FDA Regulations - Pharmaceutical and Medical Device
EudraLex - Computerized Systems
AUTOMATION
Allen Bradley – Rockwell Control Systems
Siemens, GE Fanuc
B & R Automation
Wonderware, Cypmplicity
SAFphire & SBL Programming
SCADA
COGNEX Machine Vision
Systech
Maple Systems
PROJECT MANAGEMENT
Portfolio
- All
- Engineering
- Design
- Quality
Blog
Road to success
Tower Hamlets or mass or members of propaganda bananas real estate. However, a large and a mourning, vel euismod.
Road to success
Tower Hamlets or mass or members of propaganda bananas real estate. However, a large and a mourning, vel euismod.
Contact
office@iubix.com
EmailResearch Triangle - Durham, North Carolina, USA
Address(+1) 252 452 8660
PhoneCredits
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Ethics, Competence, Professionalism: the tools to build the PATH from QUALITY to EXCELLENCE!