Project Management Quality Assurance
Resume:
LinkedIn Profile
Personal page at iubix.com
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Professional Summary
As a Certified GAMP Professional with extensive experience in FDA regulations, I specialize in risk-based approaches for remediation, QMS upgrading, process optimization, and manufacturing solutions.
My proficiency spans from design amelioration to providing requirements fitness for scope and expectations, as well as integration and fine-tuning performance improvement for automation processes.
Technical Strengths
•Manage and execute qualification projects for computer systems, equipment, and plant utilities.
•Provide engineering support to ensure reliable systems, higher performance, stability, and increased customer confidence in the quality of product realization.
Roles
•Quality Engineer, Validation Engineer, Consulting Engineer, Project Manager
Areas of Expertise
•QMS
•GxP / quality / validation: computer systems (CSV), equipment, utilities, process, software
•Manufacturing: aseptic, sterilization, lyophilization, filling, solid dose, and medical devices.
•Plant and Manufacturing Experience:
Drug and food: packaging lines (all systems and the processing from row materials to end-of-line), filling, labeling, washing and rinsing, depyrogenation
Class III Medical devices: syringe assembling and combination devices
Plant and utilities: WFI, SIP, CIP, HVAC, BMS
•Engineering expertise: electrical, automation, robotics, IT, and statistics
Career History and Details
Resilience Governmental Services (2024 - 2025)
2024 – 2025
Validation Engineer
•Provide engineering support and quality system management expertise for evaluation, cycle development, cycle evaluation and autoclave validation.
•Revalidation with focus on sterilizers, autoclaves, and incubators.
•Acting as consulting expert for evaluation and compliance remediation for clean rooms (alignment to Eudralex and ISO, and new policies).
IUBIX LLC
2005 – 2024
Senior Consultant, Quality Engineer
•Provide quality and engineering support for remediation efforts.
•Consulting for pharmaceutical and medical device companies on equipment design, testing, and qualification.
•Conduct a thorough review of commissioning, qualification, and validation protocols to ensure alignment with current regulations, guidelines, and organizational policies.
•Author qualification protocols, develop test plans and design test scripts.
•Revise the Quality Management System (QMS) for Computer Systems and Automated Process Control to support Abbott's transition to HOSPIRA.
•Serve as project manager (PM) and a subject meter expert (SME) with a focus on efficiency, continuous improvement, and timely delivery of projects.
•Mentor and train clients and their personnel to enhance their expertise and capabilities.
Korero Muna
2020 - 2024
Senior Project Manager, Quality Engineer
•Lead the IT project and coordinate the IT team to develop an innovative software solution embedded in System on Board (SoB).
•Provide expertise and technical solutions for hardware design.
•Support software development, integration, and validation processes.
ProPharma Group
2023 – 2023
Validation Engineer: Interim Cleaning Validation of Prodo-Pak filling lines
•Develop, execute, and report on interim cleaning validation processes.
•Assess the validation of CIP-100 and CIP-200 systems, including the use of detergents and cleaning methods.
•Support the assessment and validation of instruments.
•Conduct process quality assessments, develop remediation plans, and oversee revalidation efforts.
•Develop filling cycles and validate filling equipment.
Organogenesis
2021 – 2022
Quality Engineer - Validation Engineer: support for computer systems / automation
•The Growth Direct System TM (Microbial Contamination Detection):
-Configure and commission the system.
-Develop Bridge Computer Configuration Procedures, including manuals and SOPs, and oversee commissioning.
-Validate LIMS, including methods, action alert levels, handling rule creation, connections, and settings.
•ENDOSCAN-V (Endotoxin Testing Software & Data Integrity): Conduct validation of the software
•Purified Water System: Author and execute risk assessments and protocols. Provide engineering support for equipment installation, P&ID verification, startup and commissioning.
•Autoclaves: Review and approve User Requirement Specifications (URS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) protocols.
•Glass washers: Review and approve User Requirement Specifications (URS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) protocols.
•Incubators: Oversee remediation efforts.
•Passivation methods: Conduct validation of passivation methods.
Edge Pharma
2021 –2021
Validation Engineer
•Validation of incubators: author, approve and execute protocols.
•Conduct temperature mapping studies and optimizations.
•Perform stability runs to assess product integrity over time.
•Evaluate load distributions, analyze results, and implement remediation strategies.
•Execute media fill testing to validate aseptic processes.
•Conduct Growth Promotion Analysis to ensure microbial viability.
Merck
2021 –2021
Automaton / Controls Engineer for BFS line
•Provide engineering support for installation and commissioning.
•Testing and debug CIP cycles for the equipment to ensure optimal performance.
•Assist in lifecycle development by providing engineering support for the review and execution of validation documentation.
•Deliver validation support by performing impact assessments of proposed changes, determining necessary verifications, and conducting testing. Author and execute test scripts related to the changes, and document the modifications along with testing and summary reports.
Glenmark
2017 – 2020
Validation Engineer, Project Manager
•Remediate, commission, and qualify HVAC systems for aseptic manufacturing environments and laboratories.
•Integrate and revalidate WFI (Water for Injection) and OFCA (On-Farm Clean Air) systems.
•Conduct environmental studies, monitoring, and implement necessary systems.
•Provide expertise in evaluating, constructing, and testing for aseptic core construction.
•Manage projects and validation for filling lines, including sterilization, filling, and cleaning/CIP processes. Key stages include risk assessment, specifications, commissioning & qualification, and stability media fill.
•Design and retrofit packaging lines and vial filling lines.
•Oversee project management, remediation, upgrading, and commissioning for depyrogenation tunnels, lyophilizers, packaging line equipment, autoclaves, isolators, and ORABS (Open Restricted Access Barrier Systems).
•Conduct temperature mapping, engineering studies and process monitoring for sterilizers, autoclaves, and lyophilizers.
•Implement and ensure data integrity practices.
•Conduct validation and training sessions for the Kyle Validator system.
•Integrate the Blue Mountain computerized calibration and maintenance management system (CMMS).
GSK
2015 – 2016
Controls Engineer: Integration and commissioning of tableting equipment
•Design, integrate, implement, and oversee the startup and handover of automated control systems based on PLC platforms, HMI, vision systems, and SCADA.
•Provide engineering support for commissioning activities.
Phillips-Medisize
2015 –2015
Validation Engineer and quality system consultant
•Apply engineering expertise and knowledge to develop and qualify machinery for the automatic production and assembly of Class III medical devices.
•Engage in the Design of Experiments (DOE) to ensure the prototype is optimized and aligned with the established engineering processes.
•Oversee design development, FAT (Factory Acceptance Testing) execution, and provide commissioning support, including IQ (Installation Qualification) and OQ (Operational Qualification) development and traceability.
•Develop quality documentation to ensure compliance for new products.
Care Fusion
2011 - 2012
Computer Systems Quality Manager
•Architect the Computer Systems Quality Management System (QMS) by designing and implementing a quality system based on GAMP5, international standards, and established best practices. Create all supporting documents, including policies, SOPs (Standard Operating Procedures), work instructions, forms, templates, and role definitions. Mentor and train personnel on the system. Develop new strategies to improve the Change Management System.
•Execute gap assessments, recommend corrective actions, perform remediations, and develop strategic plans for improvement.
•Upgrade cleanroom QMS and implement policies to align with ISO standards and enhance environmental monitoring.
•Conduct risk assessments, review protocols, and provide approval for compliance.
Quality Engineer / Project Manager
•Lead the execution of qualifications for filling and packaging lines.
•Oversee the commissioning and qualification of applicators, assembly, and filling lines.
•Conduct validation for Agilent OpenLAB systems.
•Validate SAP business modules and author SOPs (Standard Operating Procedures) for user accounts and access control, production planning, vendor approval, material management, calibration, maintenance, and more.
Novartis - CIBA Vision
2010 –2010
Validation Engineer:
•BMS System reengineering and HVAC integration.
•Installation and qualification of the Historian/SQL database.
•Provide support for bringing the system to compliance: define requirements and draft URS and VP; gaps remediation; author and implement SOP’s.
•Conceive, execute clean rooms engineering studies and environment monitoring.
•Author protocols, quality documents and SOP’s; design test plans and test scripts, execute the commissioning and provide summary reports.
HOSPIRA
2005 – 2010
Project Manager, Validation Engineer, Controls Engineer: Plant wide support
•Lead the commissioning and qualification processes with a focus on WFI (Water for Injection), CIP (Clean-in-Place), SIP (Sterilize-in-Place), compressed air systems, packaging lines, high-speed filling, autoclaves, labeling, and tempering. Design test scripts, author qualification protocols, compile summaries, and manage submission and approval processes.
•Conduct performance qualification for autoclaves, tunnel sterilization systems, fillers, and flexible container & IV bags filling lines.
•Perform media fill studies for filling lines.
•Execute environmental monitoring studies, temperature mapping, and Mean Kinetic Temperature (MKT) evaluations.
•Conduct qualitative data analysis for spreadsheets.
•Perform software validation for control systems and automation processes.
•Redesign and oversee commissioning for commodity preparation systems (washers, rinsers), including hardware design, coding, installation, testing, and protocol execution.
•Revamp the Quality System for Computer Systems and Automated Process Control. Propose new Change Management strategies.
Education
•Bachelor of Science in Electrical Engineering (BSEE) with a focus on Industrial Automation and Communications
•Master of Science in Electrical Engineering (MSEE)
•Milwaukee Council of International Education accreditation
•Project Management (NON CAPITAL)
Training and Continuing Education
•Risk-Based Commissioning & Qualification
•FDA Regulations - Pharmaceutical and Medical Device
•Common Good Manufacturing Practices (cGMP / GMP)
•Electronic records, Data Integrity
•Software Development Life Cycle (SDLC), Software Validation, Process Validation
•HTML and CSS, W3 Schools
•Technical writing
Certifications
•GAMP 5
•Statistics - Foundations
•Statistics - Acceptance Sampling
•Allen Bradley, Siemens and B & R Automation
•FANUC Robotics
•Machine Vision Systems
•KAYE AVS
•Windows, Linux
•Microsoft Office, LibreOffice, database
•AUTOCAD, SOLIDWORKS
•Contractor Management
•Risk Regulations
•Yellow Belt
•Smartsheet
•Tableau 2024
Body of Knowledge
•Quality standards (automotive, pharmaceutical, medical devices, IT)
•Quality Management
•Risk management
•ISPE, ICH, GHTF Requirements and recommendations
•Software Quality Requirements and Evaluation
•Software Life Cycle
•Information processing
•ASTM Specification, Design, and Verification
•Application of the programming and/or related standards
•Toyota Production System
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