Dan Craciun

Dan Craciun
Validation Engineer, Controls Engineer
Quality Systems complex implementation approach to bridge process efficiency to patient expectations and
perceived value.
Risk based level expertise in heavily regulated manufacturing environments managed under quality control
standards.
Management and execution of qualification projects for computer systems, equipment and plant utilities.
Proficiency spanning from design amelioration to provide requirements fitness for scope and expectations to
integration and fine tuning performance improvement for automation processes.
Comprehensive FAT, SAT and commissioning encompassing Good Engineering Practices, consulting standards
and regulatory body of knowledge.
Engineering support that reflects on reliable systems, higher performance, stability and increases customer
confidence in quality products realization.
EDUCATION
o BSEE (Bachelor of Science in Electrical Engineering), Industrial Automation, Communications,
Polytechnic Institute of Iasi Romania - 1983
o MSEE (Master of Science in Electrical Engineering), Milwaukee Council of International Education
Accreditation - 2000
SYNOPSIS
o Years of GxP and Engineering Experience: 15+

o Areas of GxP Manufacturing Experience: Parenteral, Aseptic, Sterilization, Solid Doze, Medical
Devices
o Areas of GxP Quality / Validation Expertise: Computer Systems, Equipment, Utilities, Processes,
Packaging, BMS, HVAC, QMS
o Areas of Plant / Manufacturing Experience:
Drug and Food industries: packaging lines, filling, labeling, washing and rinsing, depyrogenation
tunnel, lyophilizer
Medical devices: syringe assembling and manufacturing, design support, process engineering,
commissioning, qualification and process validation
Plant: WFI, SIP, CIP
o Areas of Engineering Expertise:
Electrical, Automation, Robotics, IT
o Roles, Experience and Proficiency:
Validation Engineer, Software Validation Engineer, Quality Engineer, Consulting Engineer,
Project Management
o Other: Process design, automation and integration, software validation.
CAREER DETAILS
Merck (May 2021 - July 2021)
Automaton Engineer
 Assist in full lifecycle development, review, and execution of validation documentation
 Provide validation support by performing impact assessments of proposed changes, determining
required verification including testing, authoring and executing test scripts related to the changes,
and authoring of change testing summary reports.
Korero Muna (October 2020 - February 2021)
Project Manager
 Lead IT project and IT group de develop a novel software solution embedded on a SOB (System on
Board).
 Provide know-how and technical solutions for the hardware design.
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 Support software development, integration and validation.
Glenmark (2017 – 2020)
Validation Engineer
 Support for remediation, commissioning and qualification of HVAC System.
 GAP assessment and qualification for filling line, sterilization line and lyophilizer.
 Engineering support for remediation and commissioning for depyrogenation tunnel, lyophilizer and
packaging equipment.
 Kyle Validator validation
 Data Integrity implementation and usage
GSK (2015 – 2016)
Controls Engineer
 Support for design, integration implementation, startup and handover for automated control systems
based on PLC platforms, HMI, Vision Systems and SCADA.
 Support for commissioning.
Phillips-Medisize (2015)
Validation Engineer
 Engineering expertise, know-how and quality system consultant.
 Design development, FAT development and execution, commissioning support. IQ and OQ
development. Traceability.
CareFusion (2011 - 2012)
Computer Systems Quality Manager
 Architect Computer Systems Quality Management: Revamp the whole system and create all the
SUPPORTING documents (Policies, SOP’s, WI, Forms, Templates, Roles, etc.).
 Recommend directions and strategies, remove gaps and align to the industry. Guide and support
qualification execution.
 Review and approve qualification and validation protocols.
 Packaging line audits
Novartis - CIBA Vision (2010)
Validation Engineer
 Reengineer an existing BMS system. Install and qualify the Historian/SQL database
 Provide support for bringing the system to compliance: define requirements and draft URS and VP;
identify the gaps; propose changes to the affected policies and implement SOP’s.
 Conceive and execute engineering studies.
 Author protocols, execute the commissioning and provide reports.
IUBIX LLC (continuous support for on site and off site projects 2013 – 2016)
Quality Engineer
 Review commissioning, qualification and validation protocols to ensure compliance to regulations,
recommendations and policies in place.
 Co-author qualification protocols.
 Qualitative Data Analysis for spreadsheets and Mean Kinetic Temperature (MKT).
 Software Validation.
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HOSPIRA (2005 – 2008)
Validation Engineer, Control Systems Engineer
ABBOT LABS/ HOSPIRA (2003 – 2005 and 2010)
Validation Engineer
MANDRA SA – EU (various 2009, 2013, 2014, 2016 and 2017)
Controls Engineer, Quality Engineer
GENERAL MOTORS (various contract assignments from 2000 to 2002 and 2005 in US and Mexico)
Expert in controls for high level process automation. Experience on robot integration with automated
system
CERTIFICATIONS
 GAMP
 Statistics - Acceptance Sampling
 Allen Bradley – Rockwell Control Systems
 Siemens Automation and Control Systems
 B & R Automation
 FANUC Robotics
 Computers: IBM PC, mainframe, networking, data communication, OS
 COGNEX Machine Vision
 Project Management (non capital)
TRAINING AND CONTINUING EDUCATION
 Commissioning and Qualification, ISPE
 Risk-Based Commissioning & Qualification Benchmarking, ISPE
 FDA Regulations - Pharmaceutical and Medical Device
 cGMP / GMP
 EudraLex Computerized Systems
 21 CFR Part 11 / ANNEX 11, Data Integrity
 Software Development, Software Validation, Process Validation, Cleaning Validation
 HTML and CSS, W3Schools
BODY OF KNOWLEDGE
 Specification, Design, and Verification, ASTM
 ICH and GHTF (Q7/Q8/Q9/Q10 and SG3/SG4)
 Quality Management / Risk Management practices (ISO 13485, ISO 14971, ISO 14644, BS EN ISO
14698)
 Application of the programming and/or related standards (IEC 60601, IEC 61131, IEC 61499, IEC
62304, IEC 62366)
 Safety of machinery (ISO 13849, 13850, 13851)
PROFESSIONAL ASSOCIATIONS
 Member of ISPE, ASQ, ASTM
 Member of Project Management Institute (PMI)
Work Address: IUBIX LLC, Raleigh RTP, NC

Mobile phone : + 1 252 469 6948
Email : dan@iubix.com
Professional : LinkedIn Profile
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Validation Engineer, Controls Engineer

o Years of GxP and Engineering Experience: 15+

Page 1 of 3 Strictly Confidential

Work Address: IUBIX LLC, Raleigh RTP, NC

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