CONSULTING ENGINEER – FEBRUARY 2018 TO PRESENT, UB Consulting, (Pharmaceuticals (ISO 9001:2015, 21 CFR Parts 210/211 and IPEC:2017), Human Cell and tissue Products (ISO 13485:2016 & 21 CFR Parts 820 & 1271), and Medical Devices (ISO 13485:2016, FDA QSIT, and 21 CFR Parts 801, 803, 806, 820, 830, etc.), Computer/Software (21 CFR Part 11 & GAMP), Auditing (ISO 19011), Sterilization (ISO 11137) & Risk Management (ISO 14971)• Provide consulting, auditing, quality assurance, qualification and validation services. Some clients are: Allergan-LifeCell, Captiva Spine, Quality Auditing, B Braun, Spectrum Chem., EASI, Steris, Viscot Medical, Tray Pak, United-Guardian, etc.

SR. DIRECTOR CORPORATE COMPLIANCE – AUGUST 2015 TO JANUARY 2018, Drive DeVilbiss Healthcare, Port Washington, NY (Medical Devices)• Responsible for development and implementation of corporate level policies and procedures for all of Drive Medical’s Divisions and Affiliates in compliance to ISO 13485, 21 CFR Parts 801, 803, 806, 820, 830, 11, etc.• Provided guidance and support to Distribution/Warehousing, Supply Chain and Manufacturing sites (FL, PA, GA, CA, EU) in order to assure efficient operations and compliance with national & international medical devices regulations. Managed the regulatory requirements for over 8,000 medical devices items within five divisions (mobility, beds, respiratory, personal care & furniture). Managed 1 director, 1 supervisor, 2 analysts and 4 engineers.• Responsibilities include Auditing (Internal, Distributions Centers (NJ, GA, CA, NY, IN, & Canada) & manufacturing sites), Supplier Management Program (Evaluation, Qualification, & Monitoring) for over 162 medical devices suppliers, implementation of FDA-UDI, Qualification & Validation, Cost Reduction, Process Improvement, hosted corporate & sites FDA & ISO Audits, Foreign Product Registration and others. Qualified the Master Control Document Management System (DMS).

CONSULTING ENGINEER – JANUARY 2011 TO JULY 2015, UBC Consulting, (Pharmaceutical, & Medical Devices)Provide Quality Assurance Validation, Regulatory Compliance, Auditing, Project Management, Site Remediation consulting and support services. Project Leader, 2015, Secant Medical, Perkasie, PA, (Medical Devices). Responsible for developing and implementing the site qualification/validation program and other system.  Quality Lead, 2014-2015, Ciba Vision (Alcon-Novartis), Atlanta, GA, (Medical Devices). Responsible for the Product Transfer/Expansion Project of new contact lens production facility. In charge of providing regulatory guidance, review and/or approval of all deviations, CAPA’s, commissioning documents, qualification documents, validation activities, Validation Master Plan, Manufacturing Process Transfer Plan, Device Master Records, SOP’s, PM’s, and all other site/project documents and records as required. In addition, prepared the Project Cleaning Validation Assessment, Polymer Supply Plan/Schedule, Equipment Equivalence Assessment and review and approve all the Site Calibration Records  Regulatory Documentation Leader, 2014-2015, Ciba Vision (Alcon-Novartis), Atlanta, GA, (Medical Devices). Responsible for the consolidation of all contact lens Manufacturing Technical Section (MTS) Documents and DMR (Device Master Records) documents for all products.  Project Manager, 2012-2013, Novartis, Lincoln, NE, (Pharmaceutical/Consumer Products/Animal Health). Lead FDA remediation program, in charge of supervising 8 engineers, provided guidance and mentoring related to the qualification of all direct impact utilities and cleaning validation; prepare Gap Assessments, etc. . Lead auditor and Project Leader, 2011, Orthovita, Malvern, PA, (Medical Devices). In charge ofauditing the Quality Management System (QMS) and the Validation program. Developed the site validation program.

QA/VALIDATION MANAGER – OCTOBER 2007 TO DECEMBER 2010, Orasure Inc., Bethlehem, PA (Combination Products - Medical Devices & Biologics)• Hosted and supported all EU Registrar (ISO 13485) and FDA inspection audits (PAI & Routine audits). Responsible for multiple critical external supplier audits (mainland and international) and internal audits.• Responsible for the review and approval of artwork (drafts and proofs), Complaints, Change Control, CAPA, NCR’s, Technical and Design Dossier, PMA/CMC, Design Control documents for HIV & HCV testing devices, clinical trial protocols (data entry), etc. as needed.• Collaborate cross functionally for the implementation of the before mentioned system, solutions and projects. Participate in the Management Review Board, Validation Steering Committee, Non-conformance Review Board, project meetings, etc. • Managed 4 Validation engineers, 5 QA technicians and 3 QA supervisors (Incoming, CAPA/NCR, and Batch Record Review).• Developed and implemented Validation Master Plans for all validation disciplines including: Equipment Qualification, Process, Cleaning, Computer, Method, Utilities Qualification, Assembly and Packaging Validation, and Product Shipping Studies. Identified the validation gaps of the legacy products/systems for all disciplines and prepared the Site Master Validation/QA Compliance Plan. Prepared SAP ERP validation documentation package (retrospective).

• • Hired as a corrective action for FDA observations for Quality Assurance and Validation deficiencies. Developed the Quality Assurance and Validation programs to remediate all observations in less than a 2-year period as documented in the FDA establishment inspection report of Chanel dated October 2006. Supported and participated in all FDA Routine and follow-up audits.• Led the development and implementation of multiple Supply Chain/Quality/Engineering/Human Resources programs such as the Change Control program, CAPA program, Non-Conformance Investigation program, Calibration program, Preventive Maintenance program, Training program, SOP program and others.• Developed and implemented a validation plan and strategy within the Chanel Piscataway facility for achieving compliance for new and legacy drug products by using prospective, retrospective and concurrent validation methodologies. Led equipment qualification, utilities, process, cleaning, computer, method and packaging validation.• Managed 7 (peak activity level) validation engineers, 4 QA technicians/inspectors and 1 QA supervisor.• Developed a matrixed cleaning validation strategy for a multi-product facility. Coached laboratory personnel on direct surface sampling methods, swab recovery studies and analytical detection methods such as TOC and conductivity.• Led the validation of a 21 CFR Part 11 compliant Dispense Master System used for inventory and management of raw materials dispensed for the manufacturing operation (total cost was $250 thousand). Directed and guided consultants supporting the project using a SDLC methodology. Reviewed and approved all documentation ranging from the VMP, URS, FRS, GDS, TM, qualification protocols and reports. In addition, supervised the Qualification/Validation of the company SAP ERP system.

• • Responsible for the validation of the APA including the aseptic filling (media fills), component sterilization (ETO/GAMA), product sterilization (filtration) and related utilities (HVAC, HEPA’s, clean steam and USP WFI & USP PW water system). Also responsible for the qualification and validation of the manufacturing and packaging equipment/systems, plant utilities and all capital projects.• Responsible for the validation of the Parsippany-Non-Sterile Liquids Product Transfer Project. The project scope included the transfer of non-sterile liquids from the Brooklyn Pfizer facility to the Parsippany Pfizer facility ($21 million investment). The project included equipment commissioning and qualification, process validation, cleaning validation, automation and the software validation, utilities validation, facilities qualification and methods transfer.• Responsible for monitoring the departmental budget ($1.2 million) and reviewing plant change control requests in order to determine any impact on a validated process.• Assisted in the development and implementation of the Pfizer Quality Standards (PQS), hosted and participated in the FDA audits (PAI & Routine) and Corporate Quality Audits (CQA) audits.

• Managed the Aseptic Processing Area (APA) including the product manufacturing, the aseptic filling (ointment and liquids), component and product sterilization (in-process and terminal), component preparation, vial washing and depyrogenation, manual and automatic inspection (vials and ampoules) stations.• Managed the non-sterile liquid manufacturing (liquids, syrups and suspensions) area, USP WFI, USP PW, and the Clean Steam.• Responsible for managing technical specialists, equipment mechanics, filling operators, manufacturing operators, preparation operators, inspection operators, and material handlers (approximately 40-60 employees).• Responsible for the departmental SOP’s, the execution of the validation protocols (HEPAS, Media fills, room qualifications, etc.), the preparation of the NCMR, CAPA’s, deviations, change controls and the departmental budget.

• Coordinated projects with clients, contractors and subcontractors.• Supported Foster Wheeler validation efforts for Y2K software validation, computer validation and Facility Qualification.

PROCESS ASSURER, MANAGER - FEBRUARY 1995 TO JULY 1997, SmithKline Beecham. Cidra, PR (Pharmaceutical)• Managed the manufacturing and production of liquids, suppositories and solid dosages (weighing, granulation, drying, mixing, compressing and coating when required). Direct management of equipment mechanics, label room, calibration technician and operators (65 employees). Managed 8-10 packaging lines for blisters, bottles (solid, liquids), pouches, cups and ampoules.• Prepared, evaluated and/or revised SOP’s, quality investigations, customer complaints, participated in FDA audits.• Determined manpower requirements, increased productivity and prepared budgets.

• Qualified the manufacturing equipment, utilities and the facility. Syntex Pharmaceutical - HRT production.• Coordinated qualification and validation activities with clients, production and the support services departments.

• Supervised and managed solid dosage packaging lines of Merck Sharp & Dome: 40 employees; Ciba Geigy: 11 employees; and Mova Pharmaceuticals: 9 employees.• Assured cGMP’s, safety and SOP compliance and revised all packaging department SOP’s.• Developed and implemented cost reduction and enhanced productivity programs.• Supervised and trained warehouse personnel during peak production levels.

• Assisted in the implementation of MRP systems and procedures.• Led Merck Sharp & Dohme contract operations. Prepared Master Plan and Production Schedules for manufacturing and packaging for Merck Sharp & Dohme and Ciba Geigy (5 products in 62 presentations).• Performed inventory planning and management, capacity analysis, item master and BOM maintenance.• Supervised packaging and warehouse at peak production levels. Participate in improvement teams for manufacturing and logistics.• Assumed responsibility of Ciba Geigy operations from August 1991 until May 1992 in addition to fulfilling Merck Sharp & Dohme requirements.

• Taught Engineering Economy, Probability & Statistics, and Expert Systems courses to undergraduate level students in the University of Dayton, School of Engineering.