SUMMARY:

• Experienced Quality Assurance and Computer System Validation consultant, primarily in the pharmaceutical, medical device and biotech environment. Understand both process/computer validation requirements and the manufacturing / production process. Excellent breadth and depth of experience.
• 16+ years of experience in Quality Assurance and Validation in a GMP regulated industry.
• Extensive experience in pharmaceutical, medical device and biotech production environment.
• Led gap analysis, process mapping and remediation activities for process validation, CSV and software QA remediation activities per consent decree work plan.
• Coordinated and tracked remediation activities, including deviation resolution.
• Led CAPA investigation, root cause analysis, corrections, corrective actions, preventive actions, effectiveness checks.
• Risk Management, process / PFMEA, fault tree analysis, mitigation controls.
• Initiated change controls for validated processes.
• Led and trained groups of employees on quality standards and process changes.
• Team player, work well with management, vendors and operation personnel.
• Experienced with working in multidisciplinary environment.
• Excellent communication and problem solving skills.
• Willing to travel.

EXPERTISE AREA:

• Ensured project documentation complied with internal policies and procedures, and external regulations.
• Trained and coached team members (in Product Development, Manufacturing and Service) on implementation of risk management policies and procedures, and development of templates.
• Implemented processes for evaluating and investigating complaints, corrections and corrective actions using specific touchpoints between NCRs, Complaints, service reports and CAPA processes.
• Established tools and metrics for eMDR and for implementing field corrections, including the use of root cause analysis methods, risk management file, D/PFMEA and study design protocols as input to guide the required investigation level and to enable management to determine the appropriate field action and to evaluate impact on the DHFs, 510Ks and DMRs.
• Established processes and metrics for tracking non - conformances.
• Documentation for NCRs and product disposition/quarantine.
• Approval of risk analyses, periodic reviews and batch records.
• Facility validation (freezers, coolers, stability chambers, HVAC and BMS).
• Production and process controls, including process validation.
• Validation of Production Lines in Aseptic Area.
• Development, creation of test scripts and execution of Smoke Study and Media Fills protocols for a classified ISO 5 environment
• Calibration management process.
• Start - up and commissioning support and final operation hand-over.
• Cleaning systems validation (Vessels, Flow Lines, Pumps, Fillers, etc.), automated recipes, SOPs, protocol development, test scripts creation and execution, data collection and analysis (i.e., for clearing protein/product, intra-cross batch contamination), and related methodologies (SIP/CIP, TOC, conductivity, bioburden, endotoxin levels, product/agent specific assays). Compliance metrics/KPIs.
• Computer system validation (PC based systems, HMIs, Enterprise systems).
• Computerized manufacturing and packaging equipment validation (fillers, tablet presses, labelers, tanks, cartoners, cappers, checkweighers, tablet coating lines, packaging lines, CNC machines, lathes, welders, ultrasonic machines, .etc.)
• Experience in developing, test scripts creation and executing of all validation deliverables for FDA-regulated applications, including Validation Plan, Gap Analysis, Remediation Plan, URS, FRS, FAT, PFMEA, Risk Assessment, Design Specifications, IQ, OQ, and PQ Test Protocols, Traceability Matrices, Test Method Validation, DOEs, Standard Operating Procedures (SOPs), and Validation Summary Reports.
• Experienced in reviewing all validation documents, including Validation Plan, Gap Analysis, Remediation Plan, URS, FRS, FAT, PFMEA, Risk Assessment, Design Specifications, IQ, OQ, and PQ Test Protocols, Traceability Matrices, Test Method Validation, Process Validation, DOEs, Standard Operating Procedures (SOPs), and Validation Summary Reports.
• Ensured project documentation complied with internal policies and procedures, and external regulations.

TECHNICAL SKILLS:

Life Sciences: FDA Quality System Regulation, Validation Life Cycle Methodologies, Consent Decree Site Remediation, cGMP/GLP Audits, Gap Analysis, SOP Development, FDA Compliance for 21 CFR Part 11, 58, 210, 211, 803, 806, 820, and ISO/IEC 14971, 17025, 60601-1-6, 61025.

Hardware: Automated Manufacturing and Packaging Systems, PLC Systems, PC Systems, BMS.

Software: Microsoft applications (Microsoft Office, Microsoft Windows, etc.), Ladder Logic.

Languages: English, Spanish, Italian and Arabic.

PROFESSIONAL EXPERIENCE:

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Provided Software Quality Assurance Engineering support for the validation of Non-Product Software, which includes Computerized Systems and Automated Equipment such as, but not limited to, Enterprise and Quality Management applications, Crystal Reports, Regulated Spreadsheets, Medical Device Manufacturing Processes and Test Fixtures, and R&D Systems.
• Created, maintained, summarized, reviewed, and approved QA related-documentation against quality-document attributes, including but not limited to good documentation practices, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management, roles and responsibilities.
• Ensured all computer system work executed is carried out in compliance with Corporate Standards, the Validation Master Plan, the governing procedures and in alignment with other elements of the quality system.
• Proactively escalate issues and risks appropriately through proper channels.
• Provided interpretation and guidance on various SDLC methodologies.
• Performed Readiness/Auditing Review for existing validation documents to determine compliance with current procedures and regulation.
• Led CAPA activities (i.e. problem statement definition, risk evaluation, root cause investigation, corrections and corrective actions development and verification of effectiveness) for software issues.
• Participate in internal or external audits as needed
• Performed Software Quality Assurance review for validation lifecycle documentation for various medical device product families, including: Validation Plan, Change Analysis Form (CAF), Gap Assessments, URS, FRS, Software Configuration Specifications, Traceability Matrix, Risk Assessments, IQ, OQ, PQ, Periodic Reviews and Summary Reports.
• Implemented risk-based System Validation, Process Validation and Test Method Validation.
• Developed documentation for the remediation of Production and Process controls for electro-mechanical surgical equipment and instruments to address action items in the FDA Consent Decree Workplan.
• Collaborated with Product and project management teams on system-related enhancements as well as issue resolution.
• Reported on QA activities including, but not limited to process and system compliance metrics.
• Served as a mentor for junior Software Quality Assurance Engineers.
• Produced requirements documentation and equipment qualification protocols for non-automated manufacturing equipment and for calibrated measuring devices.
• Performed equipment qualification testing and verifications.
• Provided expertise in support of Design Control activities (i.e., fault tree analysis, risk management, design V&V, design transfer, manufacturing scale-up, change control and product servicing.)

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Tracked, coordinated and executed remediation activities per consent decree work plan.
• Oversaw end-to-end packaging validation activities and responsible for reviewing / auditing packaging equipment qualification and validation documents.
• Lead for validation execution and support for development and qualification activities at contract packaging sites including the transition to new Validation SOPs. The focus of this role included facilitating cross-functional alignment on validation requirements and deliverables with contract packaging sites and key stakeholders including Operations, Quality, Project Management, Site Engineering and third party auditors.
• Served as a subject matter expert with respect to validation requirements for solid and liquid dosage packaging.
• Reviewed and audited past qualification activities in support of future validations. Reviewed processes and multiple source documents in an effort to identify critical technical and compliance requirements. Developed and implemented of enhanced packaging validation processes and procedures. Provided technical input for strategic company guidelines and policies.
• Audited / reviewed of existing Qualification documentation (IQ/OQ).
• Confirmed of packaging equipment information to support development activities.
• Communicated of Company Validation requirements.
• Assessment of current documents against new standards.
• Reviewed PQ and PPQ protocols and final reports.
• Resolved issues and wrote completions reports.

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Developed, created test scripts and executed Dirty and Clean Hold Time Study Cleaning Validation protocols for a variety of pharmaceutical equipment (Bins, Utensils, Coating Pans, Granulators, Roller Compactors, Fitzmills,…etc).
• Familiar with: Swap recovery techniques.
• Created in-process information forms for detailed documentation of the manufacturing process.
• Developed, created test scripts and executed Product Hold Time Process Validation Protocols for various pharmaceutical solid dose products.
• Developed, created test scripts and Executed Process Performance Qualification Protocols (Dispensing, Milling, Roller Compaction, Fluid Bed Granulator, Tablet Compression, Tablet Coater) for various pharmaceutical solid dose products.
• Resolved issues and wrote completions reports.
• Performed Batch Records Reviews on a variety of products.

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Performed Gap Analysis and Remediation Activities for a variety of medical device documents.
• Gap Analysis included determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Remediation Activities included writing Validation Plans, Risk assessment, DOE, Process Validation, Test Method Validation, Procedures; assisting with system redesign and testing; Performance Product Validation protocols and writing validation summary reports.
• Developed, created test scripts and executed Cleaning Validation protocol for implantable devices.
• Developed PFMEA and Master Validation Plans for NurseMate and Ensite Velocity Display Workstations.
• Developed, created test scripts and executed process validation protocols, attribute and variable test method validation.
• Developed and executed IQ and OQ protocols for equipment which are used to produce automated medical device products.
• Performed Quality review for validation lifecycle documentation for various medical device product families, including: Master Validation Plan, Formal Test Plan, DOE (Design of Experiment), Process Validation, Test Method Validation, Installation/Operational/Performance Qualifications, and Summary Reports.
• Trained and led team members to develop validation lifecycle documentation including: Equipment User Requirements (URS), Equipment Functional Design Specifications (FDS/FRS), DOE, Attribute and Variable Test Method Validation, Master Validation Plan, Installation/Operational/Performance Qualifications, and Summary Reports policies and procedures and template development.
• Equipment addressed by this project are DOS PC, DWS CPU Test Fixture, Electrical Static Dissipative Monitoring Systems, Single Conditioning Units, Safety Testers, Ring Welder, Tension/Compression/Cycle Testers, EFD Dispensers, Ultrasonic Cleaners, Sealers, Zebra Printers and others.

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Developed, created test scripts and executed Validation protocols for Production Lines in Aseptic Area which is used to fill viscous products with different weights and fill volumes into syringes.
• Developed, created test scripts and executed Smoke Study and Media Fills protocols for a classified ISO 5 environment.
• Developed, created test scripts and executed Cleaning Validation protocol for a classified ISO 5 environment.
• Authored Setup and Operational SOPs for the Equipment used in a classified ISO 5 environment .
• Supported the development of the Sterilization qualifications and sterilization procedures.

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Served as primary liaison between Quality, Validation, and IT groups to manage and meet project deliverable deadlines.
• Developed and executed IQ, OQ process validation protocols for automated systems involving PLCs and HMIs.
• Systems addressed by this project are: CNC Mill machines, CNC Lathe machines, Nakamura Super NTY Lathe, Crest Ultrasonic Precision Cleaning, Crest Ultrasonic Dryers, Elastomeric Stacking, Laser Etch, 3-D assembly, Magnum Press, Sealers and others.
• Drafted and reviewed validation lifecycle documentation for Instrument software upgrade, including: Validation Plan, Requirements Traceability Matrix, Formal Test Plan, Installation/Operational/Performance Qualifications, and Summary Reports.

Confidential

Quality/Validation Engineer Consultant

Responsibilities:

• Performed Gap Analysis and Remediation Activities for a variety of medical device documents.
• Gap Analysis included determining 21 CFR Part 11 applicability and compliance, determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Remediation Activities included writing Validation Plans, Risk assessment, DOE, Process Validation, Test Method Validation, Procedures; assisting with system redesign and testing; Performance Product Validation protocols and writing validation summary reports.
• Systems addressed by this project are: Grieve Oven, Heat Staking, Tipping Machine, Brookfield Viscometer, Laser Mike, Pad Printer, Laser Welder, Flare Machine, Alcohol Flush Station, Cable Cutter, Molding Machines and others.
• Developed, created test scripts and executed validation documents (IQ, OQ, PQ, Process Validation and Test Method Validation protocols) in regards to technology transfer including equipment and processes.
• Performed Quality review for validation lifecycle documentation for various medical device product families, including: Master Validation Plan, Formal Test Plan, DOE, Process Validation, Test Method Validation, Installation/Operational/Performance Qualifications, and Summary Reports.
• Designed PFMEA documents for various product families produced at BSC.

Confidential

Senior Quality/Validation Engineer Consultant

Responsibilities:

• Led team towards validation of manufacturing equipment.
• Established Equipment Validation Schedule, reviewed and updated site Master Validation Plan.
• Performed Gap Analysis and Remediation Activities for a variety of medical device documents
• Gap Analysis included determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Remediation Activities included assisting with system redesign and testing; Performance/Process Product Validation protocols and writing validation summary reports.
• Performed Quality review for validation lifecycle documentation for various medical devices, including: Master Validation Plan, Process Capability Studies, Installation/Operational/Performance/Process Qualifications, and Summary Reports.
• Systems addressed by this project are: Glue Dispensers, Paper Counter, Tipping Machine, Pouch Sealers, Imtran Printers, Plastic Welder, Drill Press, Flat Press, Cable Cutter, Molding Machines, J-benders, Grind and Press, Welders, Ultrasonic Washing Machines, Coilers and others.

Confidential

Validation Engineer Consultant

Responsibilities:

• Performed Gap Analysis and Remediation Activities for a variety of manufacturing packaging and Laboratory equipment and control systems.
• Gap Analysis included determining 21 CFR Part 11 applicability and compliance, determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Remediation Activities included writing Process Equipment Specifications, IQ/OQ/PQ and Process Validation protocols, traceability matrices, Validation Plans, Risk assessment, URS, Procedures; assisting with system redesign and testing; writing validation summary reports; and performing retirement activities.
• Systems addressed by this project are: manufacturing and packaging equipment including fillers, assembly machines, labelers, checkweighers; cartoners, blenders, vision systems, injection molding, sterilizers, PCs and others.

Confidential

Quality/Validation Engineer Consultant

Responsibilities:

• Successfully completed the Schering-Plough Corporation 21 CFR Part 11 Remediation Quality Assurance Project Trainings. Performed gap analysis on legacy computer systems to address gaps pertaining to Electronic Records and Electronic Signatures maintained by each system. Performed technical and procedural remediation activities. Projects focused on systems remediation for Consent Decree.
• Performed Gap Analysis and Remediation Activities for a variety of manufacturing and packaging control systems.
• Gap Analysis included determining 21 CFR Part 11 applicability and compliance, determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Remediation Activities included writing As Is Functional and Design Specifications (AIFDS), IQ/OQ/PQ and Process Validation protocols, Traceability Matrices, Procedures; assisting with system redesign and testing; writing validation summary reports; and performing retirement activities.
• Systems addressed by this project are: aerosol packaging equipment including fillers, assembly machines, labelers, and checkweighers; dry powder inhaler manufacturing equipment including fillers, assembly machines, and labelers; USP Water control system; CIP control systems, liquefier and dosing tank temperature control systems; tablet presses; and tablet coating systems.
• Performed Quality review for validation lifecycle documentation.
• Coordinated change requests, document approval signatures, and validation deliverables to meet critical timelines.
• Led team of contractors/consultants through a special tablet press project in Puerto Rico.
• Developed, created test scripts and executed HVAC commissioning documents for a distribution center.
• Resolved issues and wrote the final reports.

Confidential

Quality/ Validation Engineer

Responsibilities:

• Developed Process Equipment Specifications documents for automated manufacturing and packaging equipment, involving PLCs and HMIs.
• Developed, created test scripts and executed IQ, OQ, and PQ protocols for automated labelers, fillers, cappers and tanks.
• Drafted and reviewed validation lifecycle documentation for Instrument software upgrade, including: Validation Plan, User and Functional Requirements Specifications, Detailed Design Specifications, Requirements Traceability Matrix, Formal Test Plan, Installation/Operational/Performance Qualifications, and Summary Reports.
• Served as primary liaison between Quality, Validation, and IT groups to manage and meet project deliverable deadlines.

Confidential

Validation Engineer

Responsibilities:

• Managed resolving issues and wrote final reports.
• Developed, created test scripts and executed IQ, OQ, PQ and Process Validation protocols for a variety of equipment such as filler lines, checkweighers, cappers, tanks, and receivers in a sterile environment. Resolved issues and wrote final reports.
• Executed protocols for Building Management System.
• Executed protocols for WFI and Steam systems.

Confidential

Validation Engineer

Responsibilities:

• Managed execution of protocols.
• Developed, created test scripts and executed cleaning validation protocols for a variety of equipment.
• Determined maximum residual levels of product on equipment surfaces.
• Familiar with: Swap recovery techniques, Rinse water Recovery Testing.
• Specified the basis for process validation.
• Created in-process information forms for detailed documentation of the manufacturing process.
• Developed, created test scripts and executed Process Validation protocols.
• Performed statistical analysis on product laboratory results in order to determine product uniformity and product reproducibility.
• Performed Batch Records Review on a variety of products
• Developed, created test scripts and executed IQ, OQ and PQ Protocols for a variety of equipment such as filler lines, checkweighers, cappers, and stability rooms.