SUMMARY

• Manufacturing, Production, Supplier, Vendor, Cleanroom, Discrepancy Investigations, GXP, ISO, FDA Audits, CAPAs and Effectiveness Plans. Projects completed ahead of schedule and below budget
• Building Automation Systems: Facilities / Utilities and Technical Writer
• Responsible for ensuring processes are validated to required standards and troubleshooting efforts for protocol discrepancies
• Responsible for developing protocols using a risk - based approach that meets current regulatory requirements and industry practices. Familiarity and training in ISO 14971 Risk Management; Medical Devices
• Present validation approach and protocol results to peers, management. Presenter: Trade shows and conference co-speaker
• Review and interpret data for accuracy for completed validations / re-validations, and prepare report packages by analyzing and summarizing the data to support test and protocol requirement. Packaging, 1st article, and Labeling experience
• Provide technical input to validation deviations; provide assessments for change requests on direct impact systems; and identify and research qualification and conformance requirements to ensure the validated state is maintained
• Create CAPAs (Corrective and Preventive Actions) and Effectiveness Plans to ensure incident cause is resolved
• Review, optimize, or provide SME (Subject Matter Expert) input for controlled documents relating to processes, cleaning, equipment, and computer systems validations
• Completed design verification and validation of product per FDA regulations, ISO standards, and other relevant company internal Standard Operating Procedure (SOP). Delivered high quality solutions while promoting a collaborative environment. Provided analysis, design tasks, and training for successful project initiation, execution. Experience with fishbone diagrams, event / cause discrepancies, Lab, Production, and facility investigations. Team Leader and Interim Project Manager: Leadership: Fosters communication, teamwork, keen problem solver, detail oriented, and organization skills. Listen, brainstorm, engage, interact, and negotiate effectively.
• Wrote Technical Reports. Managed material and people flow to in corporate compliance and improvements. Knowledge of continuous improvement techniques (Lean / 6 Sigma) root cause analysis techniques, GLP 21CFR 11, 58, 210, 211, and 820 (Automated Process 820.70(i), Process Validation 820.75(a-c), Production and Process Changes 820.70(b), GCP, FDA, ICH, QSR, ISO 9000 / 9001, 13485 and ISO 62304 regulations. Setup, organize, Systems, Facilities, Quality Transition plan(s). Working knowledge of EDS (Electronic Data Management) systems and computer systems (Atlas, SAP, LIMS, Livelink)
• Investigated, verified, validated products per FDA regulations, and ISO standards. Discrepancy, Root Cause evaluation, data review for accuracy and compliance ensuring Corrective, Preventative Action, Effectiveness Plans, adhere to specifications
• Provided oversight and direction for the installation, qualification, and validation of new equipment. Led and interfaced with Process Validation Department to review and approve tests, Installation Qualification (IQ) and Operation (OQ) protocols / reports. Developed / wrote User Requirements, Commissioning and Validation Summary, Full and Supplemental Validation, SOPs, specifications, testing documents, verification calculations, Protocols and Final Reports
• Set Manufacturing specifications, parameters, Review / Establish Traceability of manufacturing parameters back to documented engineering studies, Support Quality Systems, address discrepancy observations, perform audits, SOP improvement, training, Corrective Action, Preventive Action (CAPA) investigations Executed test cases / protocols and record test results and anomalies / deviations. Offer Gap Analysis Presented metrics to Management
• Led root cause analysis. Participated in risk analysis and ensured risk mitigations are properly implemented. FMECA (Failure Mode Effects Critical Analysis) experience to identify and mitigate bottlenecks, and critical risk for development teams.
• Develop engineering policies, technical work with Engineering Management, per project and business objectives. Provided engineering technical support and project management for problems and projects related to small through full scale manufacturing operations, environmental containment, facilities design, personnel and facility safety, and regulatory issues. Created change control documents. Member of Change Review Board
• Identified, qualified, and audited vendors for contracted services, purchases, and supervised activities to ensure compliance with approved project scope of work documents. Conducted PM meetings for Vendors and internal business units to determine customer needs, develop solutions, and investigate discrepancies
• Participated in System Integration Tests. Monitor project lifecycle, balance multiple tasks / priorities; met deadlines.

PROFESSIONAL EXPERIENCE

Confidential

Sr. Validation Engineer

Responsibilities:

• Met project deliverables: Produced and / reviewed verification and / validation plans, protocols, reports, execution of the plans, reviewed / resolved deviations, review previous Validation / Verification, Commissioning & Qualification (C&Q) documents, Engineering Test Matrix (IQ), during return to service of a world class Manufacturing facility. Member of Special Project Team
• Assisted Facilities and Systems Engineers, Project Management, Marketing, Quality and Regulatory personnel to prepare, and executed IQ, OQ, and PQ Protocols for Water-for-Injection (WFI), Clean Steam, Compress Gases CO2; Washers, Cold Room
• Supported development testing, special projects, and characterized designs. Managed timeline

Confidential

Sr. Validation Engineer

Responsibilities:

• Reviewed Validation Process, Wrote / reviewed Equipment Periodic Reviews for verification of validated state of Manufacturing Equipment of previous Validations, i.e. Freezers, Autoclave Operation, Bioreactors to include, not limited to: UF skids, filtration systems, vessels, transfer lines, environmental monitoring, DCS Trends, and P&ID's, or Piping & Instrumentation Flow Diagrams, Process Flow Diagram (PFD), Water for Injection (WFI) cGMP, FDA and Support Cleaning Validation Campaigns
• Wrote / Supported Cleaning, Equipment, Computer System Validation (CSV) Process Validation, and Methods Validation
• Experienced Lead Auditor, Quality Assurance Engineer (QAE), Quality Control (QC), and Quality Assurance (QA).
• Assessed Pharmaceutical, Medical Device, Biotech, Biopharma, and Pharmaceutical processes, procedures, and Equipment

Confidential

Sr. Consultant, Validation Engineer

Responsibilities:

• In 2.5 months: 6 Reports - Led Team that remediated ~165 documents, 118 Raw Materials (Method Validation Protocols, Periodic Reviews, Final Reports)
• Managed conversion; not cGMP to cGMP materials; Led Periodic Reviews, Gap Analysis, Protocols, Final Reports
• Managed preparation of Validation deliverables for presentation to QA for approval
• Collaborated with QA and Management team, to strategized and determine the most effective solutions; created reports, logged discrepancies; tracked documents, routing, reviews, approvals, and Final Report binder releases
• Led Validation Team to perform analysis of current business processes and translate development of documents