DAGMAR BON

**** ******** *** #*** *********, CA *4550

510-***-**** adhs9f@r.postjobfree.com

Proven professional, effective problem solver with experience in Compliance, Quality, CAPA and Validation for Medical Devices and Pharmaceuticals

Quality-Validation-CAPA, Automation, Commissioning Process Controls, Validation and Project Management professional with extensive experience of regulations cGMP, GxP, FDA, ICH, EU, ISO and 21 CFR 11, 820 related to Pharmaceuticals, Biotechnology, Medical Devices and Computerized Systems.

CERTIFICATIONS

Project Management Professional (PMP) ® Credentials Six Sigma Certification

Total Quality Management Certification Root Cause Analysis

SPECIALIZATIONS & SYSTEMS

21 CFR Part 11, (HIPAA Security- proposed);Annex 11 (EC GMP), IEC 62304; ISO 14644, 14698, 9001:2000, 13485, GAMP 5, Gap Analysis, Risk Assessments, Software Validation, Windchill, Delta V, DCS, Primavera/Agile, Scrum, Oracle, ERP, Rockwell Factory Talk, SAP, MES, Mainsaver, Millennium, LAC/E Acquisition, TQM, SQL, PL/SQL, Windows Servers, Webservers, Web/Cloud Applications, Client/server, Microsoft Project Management, Process Analysis, Remediation Plans, Software Quality Assurance Test Plans/Scripts, Validation Master Plans / Validation Reports, Lifecycle Development (SDLC) Autoclaves, Dryers, Washers, Chromatographers, Isolators, Ovens, Bioreactors, Laboratory Equipment, HVAC, Washers, Dryers, Fermentors, Tanks, Cleaning Cycle Development, Stability Chambers, Cold Rooms, Temperature Mapping, Water Systems, Sterilization, Serialization, ALCOA +

EXPERIENCES AND ACHIEVEMENTS

Bond Consulting, LLC Pr. Project Validation/Quality Engineer 2019 - 2020 FDA remediation project, for Equipment, Process, Utilities and other validation activities (ex. IOQ/PQ, Commissioning, Design & Development, Process Validation, Test Method Validation, Quality and Testing, Delta V. Evaluate all existing equipment, utilities and facilities for compliance.

Edge Pharmacy Service Pr. Project Engineer 2018 - 2019

Support client’s entire FDA remediation project for the Cleanroom/Facility, Equipment, Cleaning, Process, Utilities and other validation activities (IQ/OQ/PQ, Design Specification, D&D, Commissioning, Test Method Validation, Testing, Data Integrity using ALCOA principles). Evaluate all existing equipment for compliance, refrigerators, ovens, autoclaves, isolators, incubators, sterilizers, testing equipment, and process related equipment. Wrote new SOPs for facility cleanroom, cleaning, utilities, equipment, processes, calibration and routine maintenance. Audited the client’s calibration systems and tracking mechanisms for all in-house equipment.

Natus Pharmaceuticals – Pr. Validation Project Engineer 2017 - 2018

Conducted investigations using a variety of root cause tools for several validation projects to be in compliance with 21 CFR Part 11, IEC 62304 and ISO 13485. Performed procedural assessments against defined requirements for gaps to define the levels of validation needs, D&D, Quality Systems, CAPA’s, Equipment Validation. Wrote and executed MVP, URS, FS, TM, SCS, IQ, OQ, PQ, Test Scripts.

Assessed high visibility cGMP manufacturing and laboratory systems for compliance, analyzed how CAPA’s and remediation activities were conducted and how validation issues were solved

Fujifilm - Delta V Project Engineer 2017

Worked with a team of engineers, operations, vendors, contractors and other project team members to investigate and complete all validation deliverables related to the Delta V Infrastructure, all the utilities, facilities and equipment connected to Delta V (Tanks, Fermentors, autoclaves, WFI, RO/DI, CIP, SIP, compressed air, manufacturing suites, etc.). Follow FDA 21 CFR Part 11 for Data Integrity and Compliance for their sterile/aseptic facility. Authored automation design and testing documents for all phases (SAT, FAT, Commissioning, MVP, URS, FS, TM, SCS, IQ, OQ, PQ, Test Scripts), ALCOA +

Raland Compliance Partners Validation Project Manager 2016

Project Manager of a validation effort in Juarez, MX. Lead a team of local employees validate and qualify their electromechanical box-build and PCBA manufacturing facility transfer for medical devices with serialization, Test Method Validation (TMV), ALCOA Methodologies.

Pharmabiodevice Consulting LLC, Principal Quality Validation Consultant 2016

Subject Matter Expert (SME) in Quality and Compliance, Data Integrity, Batch Record Review, Auditing, FDA Remediation, Quality Systems Investigations and Non-conformances (CAPAs, Deviations, OOS), Validation (Systems, Equipment, Processes), Sterilization processes (Ethylene Oxide, Gamma), with expertise in National and International regulatory bodies’ regulations and compliance requirements associated with Sterile injectable, Biologics, Pharmaceutical, and Medical Device Products. In charge of the investigations for their sterile/aseptic facility for Data Integrity, ALCOA and ALCOA +.

Gerson Lehrman Group Council Member 2016

Providing expert-level advice to medical device, biotech and pharma leadership, institutional investors, private entities and professional services firms on development strategies, meeting timelines, budgets and other objectives and tackling challenges in critical moments, to make informed decisions for multi-million dollar investments and sound and confident business venture decisions for the firms’ short and long-range portfolio strategies. Ex: SAP, ERP, Oracle, MES, Agile, LIMS and Delta V - SME).

Patheon, Italy Data Integrity /Quality Compliance Engineer 2015 to 2016

Perform investigations, audit, review of already completed batch records and associated data as well as significant deviations associated with each batch for their sterile/aseptic facility. Develop and submit a summary of findings with recommendations for batch disposition. Audit process validation for remediation. Mentor the Italian team in how to streamline their process controls, ALCOA.

PneumRx Process Validation Engineer 2015 to 2016

Perform engineering work focusing on the procurement, design and development, documentation, investigation, Test Method Validation (TMV) as well as installation of manufacturing equipment. Establish work instructions for manufacturing operations. Support process validation program; responsible for monitoring, mentoring, and supervision of the QA investigation and complaints.

PharmEng – Assigned to Alcon Principal Quality Validation Engineer Consultant 2015 Managed and executed process and test method validation projects at their sterile/aseptic facility for Autoclaves, SIPs/CIPs, Media fills, Hold times, Freeze Dryers, Reactors, Gamma Sterilization, Filtration and Eto. Investigated deviations to prepare validation plans for process, equipment for their sterile/aseptic facility. Reviewed, updated and re-executed their Delta V and SCADA Infrastructure IOQ. CAPA Investigations and Reports.

tConducted validation protocols and reports in support of corporate validation program

tInvestigate and troubleshoot problems which occur during the cleaning validation studies

ALKU – Assigned to Gilead Sciences Software Quality Engineer Consultant 2014 to 2015

Managed vendors, resources and validation documentation for plant control systems (LabWatch, Trackwise and PCS Factory Talk) in accordance with 21 CRFR part 11, Annex 11

tDocumentation was for new API pilot plant MVP, URS, FS, DS, Trace Matrix, Risk Assessment,

IQ, OQ, PQ, V&V and Test Scripts

tExperience administering QMS, LMS, stability management systems, and SharePoint base systems Experience managing GxP Computerized System implementation projects

Goode Compliance Int’l – QSCS

Assigned to: Biomet 3i Sr. Quality Consultant 2014

Assisted the Quality Department to investigate and resolve their Non-Conformances for the PSP (Patient Specific Product) Division. System Integration/Harmonization activities; including Investigation & CAPA Systems

tWrote protocols (IQ, OQ), and provided technical support to manufacturing, process validation, V&V and R&D, CAPA process

Assigned to: Hospira Sr. CAPA Engineer

Conducted 3rd party investigations at their sterile/aseptic facility to ensure activities were clearly documented and implemented to fulfill regulatory/business requirements. Investigated batch records for data integrity and remediation, also ensured that problem root causes were adequately

investigated. Managed quality issues according to procedures and that corrective /preventive action were effective to eliminate/mitigate issues, participated on the Corporate CAPA Review Board (CRB)

Fresenius, Guadalajara, Mexico and Canada Sr. CAPA Engineer 2013 to 2014

Responsible for the timely initiation, investigation, implementation, and monitoring of assigned CAPA/NC projects. Partnered with Quality Systems personnel to drive continuous improvement on Root Cause investigations. Completed assigned CAPAs and acted as CAPA Owner/Team lead providing guidance to the team(s). Supported the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements), to ensure quality issues were managed according to procedure and adequate corrective /preventive actions are effective to eliminate/mitigate the issues.

tLead CAPA Investigations/Teams to ensure adequate identification, evaluation & investigation to root cause. Writing and executing protocols (IQ, OQ, PQ), and proving technical support to manufacturing, process validation, V&V, R&D and CAPA process

tEnsured investigations and activities were clearly documented and implemented to fulfill regulatory and business requirements, participate on the Corporate CAPA Review Board (CRB).

Reglera Corporation- Denver, CO 2005 to 2013

Assigned to: Tissue Banks Int’l Sr. Quality Compliance / Validation Engineer 2013

Wrote and executed protocols (IQ, OQ, PQ) proving technical support to manufacturing, process controls, process validation and R&D for their tissue harvesting process and organ preservation before transport for transplant. CAPA Process streamline.

Assigned to: Zimmer Spine Sr. Supplier Quality / Validation Engineer 2013

Updated Zimmer’s FURLS (FDA Unified Registration and Listing System) for vendors to be in compliance as required by 21 CFR 820.198 and a corporate CAPA.

Assigned to: Boston Scientific Sr. Quality Validation Engineer/Project Manager 2005 to 2013

Accomplished a 483 Remediation Project, writing and executing MPV, VP, IQ, OQ, PQ, PPQ, aTMV, vTMV, pFMEA, Gage R&R, ANOVA, ALCOA, Complaint Analysis, Design Validation and Verification, Shelf Life Studies, DHF, Packaging Validation, CAPAs, Gap analysis, Risk Assessments, Remediation Plan, Software Validation, and a Packaging validation project with serialization. Experience in EDMS, QMS, LMS, eCTD, stability management systems, SharePoint base systems, GxP, Computerized System implementation projects. Developed systemic enhancements and training program (for investigations) which resulted in streamlined processes.

tProvided technical support to commissioning, manufacturing, process development, process controls, equipment engineering and R&D

tLed corporate quality improvement initiatives and managed multiple projects

Assigned to: Stryker Corporation, Fremont, CA (Boston Scientific Neurovascular acquisition)

Sr. Quality / Validation Engineer/ Supplier Quality Engineer/Project Manager

Wrote procedures including Validation Plans including Software, SOPs, WIs, Life Cycle

and for structuring departments Facilities, EHS, Security, Calibration and Supplier Quality Departments. Transfer from SAP and MES to JD Edwards EnterpriseOne, ERP (VMP, URS, FS, SCS, IQ, OQ PQ, PPQ, Test Scripts and Final Reports) in accordance with 21 CFR part 11, Annex 11 and IEC 62304. Created work instructions for First Article Inspection, Supplier Process Change Control development for Stryker Neurovascular QMS, Calibration, Supplier Controls. Incoming Quality Assurance and Material Specifications/Inspection Procedures.

tProvided technical and quality support to Compliance Quality, Facilities, R&D, Operations and Calibration, part of the transition- divestiture team from Boston Scientific to Stryker

tDeveloped a strong collaborative relationship with service and component suppliers (on-shore, off-shore) to ensure the continuous supply of compliant materials to manufacturing

tMaintained supplier development through selection, onboarding, maintenance and audit

tCommissioned Validated and Integrated BMS system from start to finish

EDUCATION

BS/MS Information Technology - Software Systems Engineering Specialization, Colorado Technical University

Master’s Degree, Biochemical Engineering, Iowa State University

Bachelor of Science, Chemistry - Biology, University of Puerto Rico

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