SUMMARY:

• Analytical and forward - thinking engineer with Packaging, Validation, and Process Engineering experience.
• Demonstrated success working in dynamic R&D, Quality, and Manufacturing environments that are regulated by 21 CFR 210/211 (Pharmaceutical), 820 (Medical Device), and 4 (Combination).
• Adept at developing lifecycle documentation, including IQ/OQ/PQ, User Requirement, Procedures, Packaging Validation, and Technical Reports.
• Solid background in compliance with Confidential regulations, ISO standards, and ISTA standards for the Medical Device and Pharmaceutical Industries.
• Highly skilled in Quality Management Systems including Change Controls, Deviations, CAPA’s, FMEA, Risk Analysis, GAP Analysis Investigations and Periodic Reviews.
• Driven to achieve results and exceed expectations to ensure the long-term and sustained success in building a strong relationship with clients. Self-motivated with the ability to work independently as well as in teams.

SYSTEMS KNOWLEDGE BASE AND SKILLS:

Products and Technologies: Injectable, and Inhalable Pharmaceuticals Packaging Lines, Prefilled Syringes, Dental and Spinal Bio-Pharmaceutical Product, Knee and Hip Replacement Implants, Spinal Implant and Fusion Products, Cardiovascular Stents and Balloon Catheters, Instruments and Ventricular Assist Device (VAD), Diagnostic Equipment, Surgical and Trauma Kits, Surgical Power Tools, Sterile and Non-Sterile Wound Care, Wheelchairs and Disability Scooters.

Qualification and Validation: Authoring of Templates, Protocols, Documentation Execution and Summary Reporting for FAT/SAT Commissioning, Validation Planning, IQ, OQ, TMV, PQ, SOP’s, WI’s, NCR’s and/or CAPA’s.

Tool: box: Oracle, Agile, SAP, TrackWise, PDOCS, Minitab (DOE, ANOVA), Pallet Pattern programs (CAPE, TOPS), GxP Excel Spreadsheet Systems, Microsoft Office/Project, Visio.

Regulatory Compliance: Authoring and/or providing assurance in provisions for prerequisite assessments and documentation for the DRS/FRS, URS, RA’s, DFMEA, PFMEA, ERS, DOE’s, Product Characterization, Critical Process Parameter Development Gage R&R, SOP’s and WI’s.

Regulatory Controls: cGMP’s and Requirements Specifications 21 CFR, Parts 3.2(e), 4, 11, 210, 211; 820, ISO 13485, ISO 14971, ISO 14644, ISO 11607, ISO 9000, ISO 9001; ISTA Standards; CMDCAS; and EU Directives.

CLIENT AND WORK HISTORY:

Confidential

Senior Validation Engineer

Responsibilities:

• Implementation and Validation of Optel Serialization system across all manufacturing lines in Confidential Kansas.
• Author Requirement Traceability Matrix (RTM’s) for Computer Systems.
• Evaluate Computer Systems to determine if systems should be classified as GxP applicable.
• Generate reports based on findings.
• Perform Electronic Records and Electronic Signatures (ERES) GAP assessments for Optel Vision TrackSafe Systems and supporting documentation.
• Generate summary reports based on GAP analysis findings.
• Ensure documentation compliance with Confidential and GLP regulations and provide technical support to the Serialization group.
• Execute Validation protocols which included IOQ and PQ runs.

Confidential

Senior Packaging Equipment Engineer

Responsibilities:

• Led activities with validation team leader and project teams to execute Site Acceptance Testing (SAT), Installation and Operational Qualification (IOQ) protocols.
• Developed and executed protocol for Factory Acceptance Testing (FAT) documentation.
• Authored and executed Engineering Technical Study Protocols.
• Directly provided engineering support to validation team leader to author User Requirements Specifications (URS) for a newly constructed $15 MM fully automated and serialized combination device assembly/packaging line.
• Managed process and product commodities for qualifications.

Confidential, Lancaster, PA

Senior Validation Engineer Consultant

Responsibilities:

• Authored and executed IOQ protocols on all shock, vibration and compression testing equipment. Additionally, authored the corresponding summary reports for the equipment.
• Created standardized templates for IOQs and test data sheets.
• Authored Standard Operating Procedures (SOP) and Requirements Traceability Matrix (RTM) for a Lansmont Vibration Table.
• Provided technical support to the Validation and Medical Device Package Testing group by ensuring the documentation met cGLP and was compliant with Confidential regulations.

Confidential, Utica, NY

Senior Packaging Engineer Consultant

Responsibilities:

• Implemented new sterile barrier packaging systems in compliance with internal and external standards.
• Enhanced the design and transportation testing (ISTA) of non-sterile package system as part of a cost savings initiative.
• Developed criteria for package component acceptance and transfer into inventory.
• Optimized the sealing parameters by performing a DOE and analyzing the data.
• Installed and qualified new packaging equipment. Authored IQ/OQ/PQ protocols and summary reports.
• Authored and executed Design Verification protocols and summary reports to qualify new packaging materials/systems.
• Performed GAP assessment on previously executed package Design Verification testing, generated summary reports and made recommendations based on findings.

Confidential, Augusta, GA

Senior Packaging Engineer

Responsibilities:

• Performed GAP assessment on seven Multivac packaging lines and all related equipment and processes.
• Generated summary reports based on GAP analysis findings and made recommendations on equipment, processes and packaging documentation.
• Authored and /or revised TMV’s, WI’s and SOP’s based on GAP analysis findings.
• Responsible for conducting and coordinating training of operations personnel on WI’s and SOP’s.
• Performed CAPA assessments to determine root cause under established SOP’s to initiate corrective action plans.

Confidential

Senior Quality Engineer

Responsibilities:

• Led process transfer of current products to CMO.
• Authored and executed validation protocols and summary reports for three existing assembly line transfers between facilities.
• Developed non-sterile package redesign, component consolidation and sustainability initiatives.
• Ensured that all modifications made were incorporated to DHR.
• Established uniform packaging acceptance criteria and inspection procedures for international point of sale locations.

Confidential, Memphis, TN

Senior Quality Engineer

Responsibilities:

• Identified critical process parameter criteria to support existing process validation.
• Performed risk assessments and CAPAs on existing design and process FMEA’s.