Project Management Quality Assurance

I use a quality systems implementation approach to bridge process efficiency to patient expectations and perceived value.

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.

Perform comprehensive FAT, SAT, and commissioning in accordance with Good Engineering Practices, consulting standards, and regulatory requirements.

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.

EDUCATION

oBachelor of Science in Electrical Engineering (BSEE) with a focus on Industrial Automation and Communications

oMaster of Science in Electrical Engineering (MSEE) accredited by the Milwaukee Council of International Education

oProject Management

oGAMP 5

SYNOPSIS

oAreas of expertise in GxP quality and validation include: Computer Systems, Equipment, Utilities, Process, Packaging Lines, BMS, HVAC, and QMS

oManufacturing experience in GxP includes: aseptic, sterilization, lyophilization, filling, solid dose, and medical devices.

oAreas of Plant and Manufacturing Experience:

-Drug and Food industries: 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 manufacturing

-Plant: WFI, SIP, CIP

oAreas of Engineering Expertise:

-Electrical, Automation, Robotics, IT, and Statistics

oRoles, Experience and Proficiency:

-Quality Engineer, Validation Engineer, Consulting Engineer, Project Management

oOther areas of expertise include: process engineering, automation and integration, software validation, and process validation

CAREER DETAILS

IUBIX LLC (Consulting roles 2005 – present)

Senior Consultant, Quality Engineer

Provide quality and engineering support for remediation.

Offer consultancy for pharmaceutical and medical device companies for equipment design, testing and qualification.

Review commissioning, qualification and validation protocols to ensure compliance to regulations, recommendations and policies in place.

Co-author qualification protocols.

Revamp the QMS for Computer Systems / Automated Process Control (for Abbott transitioning to HOSPIRA).

Act as project manager with focus on efficiency, improvements, delivering on time.

Mentor and train customers and their personnel.

Korero Muna (2024, 2022, 2021, 2020)

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.

ProPharma Group (2023)

Validation Engineer: Interim Cleaning Validation of Prodo-Pak filling lines

Interim cleaning validation development, execution and reporting.

Assessment of CIP-100, CIP-200, detergent’s use and cleaning methods validation.

Supporting instrument assessments and validations.

Process quality assessment, remediation plan and revalidation.

Filling cycles development and filler validation

Organogenesis (2021 – 2022)

Quality Engineer - Validation Engineer: support for computer systems / automation

The Growth Direct System TM (Microbial Contamination Detection):

-Configuration and commissioning

-Bridge Computer Configuration Procedures (manuals, SOP) and commissioning

-LIMS validation (LIMS Methods, Action Alert Levels and Handling Rule Creation, LIMS Connections, and LIMS Settings)

ENDOSCAN-V (Endotoxin Testing Software & Data Integrity) validation

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 URS, FAT and SAT protocols.

Glass washers: Review and approve URS, FAT and SAT protocols.

Incubators remediation

Passivation methods validation

Edge Pharma (2021)

Validation Engineer

Validation of incubators: author, approve and execute protocols.

Temperature mapping studies and optimizations.

Stability runs.

Evaluate loads, analyze and remediate the effect of distribution.

Execute media fill testing.

Growth Promotion Analysis

Merck (2021)

Automaton / Controls Engineer for BFS line

Engineering support for installation and commissioning.

Testing and debugging CIP cycles for the equipment.

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 for the manufacturing aseptic environment and for the laboratories.

WFI and OFCA system integration, and revalidation.

Environment studies, monitoring and system implementation.

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

Project management and validation for filling lines (sterilization, filling and cleaning / CIP). Stages: risk assessment, specifications, commissioning & qualification, stability media fill.

Design and retrofit packaging lines and vial filling line.

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

Data Integrity implementation and usage.

Kyle Validator validation.

Blue Mountain computerized maintenance management system (CMSS) integration

GSK (2015 – 2016)

Controls Engineer: Integration and commissioning of tableting equipment

Design, integration implementation, startup and handover for automated control systems based on PLC platforms, HMI, Vision Systems and SCADA.

Engineering support for commissioning.

Phillips-Medisize (2015)

Validation Engineer and quality system consultant

Apply engineering expertise and know-how for developing and qualification of machineries for automatic production and assembling of Class III medical devices.

Design development, FAT development and execution, commissioning support. IQ and OQ development. Traceability.

Develop quality documents for the new products compliance.

Care Fusion (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, gap assessment and remediation and upgrade the quality system to the regulatory body and the industry standards.

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

Risk assessments, protocols review and approval.

Quality Engineer / Project Manager

Lead qualification execution for filling and packaging lines.

Commissioning and qualification for applicators assembling and filling lines.

Agilent OpenLAB validation

SAP business modules validation and SOPs authoring (user accounts and access control, production planning, vendor approval, material management, etc.)

Novartis - CIBA Vision (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 scripts, execute the commissioning and provide reports.

HOSPIRA (2005 – 2010)

Project Manager, Validation Engineer, Controls Engineer: Plant wide support

Commissioning and qualification with focus on WFI, CIP, SIP, Compressed Air, packaging lines, high speed filling, labeling, tempering. Design test scripts, author qualification protocols, compile summaries, submit and approve.

Performance qualification for autoclaves, tunnel sterilization, fillers and flexible container filling line.

Perform filling lines media fill.

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

Qualitative Data Analysis for spreadsheets.

Software Validation (for control systems and automation).

Redesign and commissioning for commodity preparation (washers, rinsers): hardware design, coding, installation, testing and protocols execution.

Revamp the QMS for Computer Systems / Automated Process Control

ABBOT LABS/ HOSPIRA (2003 – 2005 and 2010)

Validation Engineer

GENERAL MOTORS (various assignments from 2000 to 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.

Complete design (specifications, functionality, layout, integration, coding, networking, BOM and purchasing, installation, team lead and contractor supervision, startup and debugging, mentoring and training).

CERTIFICATIONS

GAMP 5

Statistics - Acceptance Sampling, Validation and Manufacturing Sample Plans

Allen Bradley / Rockwell, Siemens Automation and B & R Automation

FANUC Robotics

Machine Vision Systems

KAYE AVS

PC Computers, mainframe, networking, data communication, Windows, Linux

Microsoft Office, LibreOffice, database

AUTOCAD, SOLIDWORKS

Contractor Management

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, W3 Schools

Technical writing

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, ISO 14698, ISO 9001)

Risk management – Guidelines (ISO 31000:2018)

Software Quality Requirements and Evaluation – SQuaRE (ISO 25000 Series)

Software Life Cycle (IEEE 12207)

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)

Toyota Production System (TPS), KAIZEN

PROFESSIONAL ASSOCIATIONS

Member of ISPE, ASQ, ASTM

Member of Project Management Institute (PMI)

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