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

oBSEE (Bachelor of Science in Electrical Engineering), Industrial Automation, Communications, Polytechnic Institute of Iasi Romania - 1983

oMSEE (Master of Science in Electrical Engineering), Milwaukee Council of International Education Accreditation - 2000

SYNOPSIS

oYears of GxP and Engineering Experience: 15+

oAreas of GxP Manufacturing Experience: Aseptic, Sterilization, Solid Doze, Parenteral, Medical Devices

oAreas of GxP Quality / Validation Expertise: Computer Systems, Equipment, Utilities, Processes, Packaging, BMS, HVAC, QMS

oAreas 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

oAreas of Engineering Expertise:

Electrical, Automation, Robotics, IT

oRoles, Experience and Proficiency:

Validation Engineer, Quality Engineer, Consulting Engineer, Project Management

oOther: Process design, automation and integration, software validation.

CAREER DETAILS

Korero Muna (October 2022 - February 2023 and 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.

Support software development, integration and validation.

Organogenesis (November 2021 – May 2022)

Validation Engineer

Validation support for Computer systems / Automation with focus on Purified Water and Autoclaves.

Author and execute risk assessments and IOQ protocols.

Review and approve FAT and SAT protocols.

Edge Pharma (August 2021 - October 2021)

Validation Engineer

Validation of incubators: author protocols, execute temperature mapping, evaluate loads, analyze and remediate the effect of distribution.

Execute qualification protocols.

Merck (May 2021 - July 2021)

Automaton Engineer

Assistance and engineering support for 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, documenting changes, testing and summary reports.

Glenmark (2017 – 2020)

Validation Engineer, Project Manager

Remediation, commissioning and qualification of HVAC System.

Environment monitoring and environment studies.

Expertise for evaluation, construction and testing for aseptic core construction.

Project management and qualification for filling line and sterilization line.

Project management for remediation, upgrading and commissioning for depyrogenation tunnel, lyophilizer and packaging equipment.

Kyle Validator validation.

Data Integrity implementation and usage.

GSK (2015 – 2016)

Controls Engineer

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.

Packaging line audits

Clean rooms QMS upgrade and policies implementation to align with ISO standards and for improving environment monitoring.

Project Manager

Lead qualification execution for filling and packaging lines. Review and approve qualification and validation protocols.

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, execute clean rooms engineering studies and environment monitoring.

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.

Environment monitoring studies, temperature mappings, and Mean Kinetic Temperature (MKT) evaluations.

Software Validation.

HOSPIRA (2005 – 2008)

Project Manager, Validation 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)

Controls Engineer, Project Manager

Project management for execution of automated assembling lines and technological processing cells.

Applied expertize of 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

21 CFR Part 11 / ANNEX 11, Data Integrity

Software Development, Software Validation, Process 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

Professional : LinkedIn Profile

Personal page

E-mail to: adxcna@r.postjobfree.com

Contact this candidate