Hospira, KS - Automation Engineering Support
FTE backfill role performing automation engineering work stream. Included drafting and presenting Business Case, developing Request for Capital Expenditures (RCE), Project Charters, Schedules, Change Controls, Work Orders and Turn Over Packages for Automation Projects to be executed over plant shutdowns. Projects included: Lyo Controls Upgrades, Particle Counter Installations, EMS panel expansions (T+H+DP), Andon installation and RO Water Upgrades.
Biologics Manufacturer, Inc., Boulder, CO – Process Validation and Record Review/Investigation
Process validation development and execution for a reintroduced biologic process. Included development, execution, non-conformance investigation support, batch record review, SCADA data analysis and summary Batch disposition.
Oakwood Labs, Solon, OH – Facility Master Plans, Qualification and SOP support
Partnered with VP of Quality to develop a site Validation Master Plan, SOPS and support the facility remediation effort. Additionally, included development and execution of qualification documentation for: depyrogenation ovens, aseptic filling, sealing, labeling and encoding equipment.
Sandoz, NJ - Third Party Quality Representation for New Product Launch
Represented as Third Party Quality representative as person-in-plant at a sterile injectable site. Performed batch record reviews, validation protocol drafting and reviews, ER closure, audit resolution, CAPA alignment and batch tracking for a new sterile injectable product launch
Hospira, KS - Resource Modeling at Generic Injectables Facility
Partnered with management to define roles and responsibilities for equipment maintenance & operation teams at the site. Created a baseline survey of maintenance groups, and reported the findings to management. Evaluated existing process and worked with floor personnel to update job descriptions for each group. Drafted a shift change procedure for clear communication between shifts. Created and tracked Key Performance Indicators (KPIs) for Operations and Maintenance groups. Formed a Pilot group to test new R&Rs, shift change procedure, and KPIs.
Hospira, KS - Evaluation of GxP Inventory Project
Worked with Quality and Validations to update validation and plant SOPs in regards to GxP assessments and Computer Systems Validation. Inventoried and evaluated GxP-relevant systems for validation deficiencies. Created an inventory of all production systems, computerized databases, and laboratory spreadsheets. Identified discrepancies in the electronic and physical production equipment inventories. Evaluated laboratory databases and spreadsheets for Federal regulation compliance and formed remediation plan.
Talecris Biotherapeutics, NC- Biologics Processing Facility
Project Management, development and execution of complete process commissioning and qualification, and process and cleaning validation for a product transfer from multiple facilities. Included protocol (development and functional) development, execution, exception resolution and final reports. Equipment included: buffer and process vessels, chromatography skids, UFDF skids, nanofiltration skids, CIP skids, analytical instruments, blast freezers, and bulking operations. Document deliverables included commissioning and qualification structured per ASTM E2500.
Allergy Laboratories, OK - Quality Remediation/483 Response Team Support
Provided quality, operations and engineering support to address both self identified and FDA 483 identified quality issues. Phase I consisted of addressing FDA Observations by performing in depth fishbone investigations to determine product release and develop a list of CAPAs to provide long term solutions. Phase 2 included review/revision of SOPs, change controls, and qualification studies and provide recommendations for compliance.
Ben Venue Labs, Cleveland, OH
Vial inspection vision system commissioning and qualification. Vision system downstream of aseptic filler for vial inspection. Included commissioning, engineering study to determine operating parameters and qualification. Drafting, execution and final report generation.
Ben Venue Labs, Cleveland, OH
Development of process validation for 3 aseptic filling lines. Included determination of operational parameters and equipment linkage from vial washing, depyrogenation tunnels, filling, sealing and exterior vial washing. Drafting, execution and final report generation.
Sonexus (Cardinal Health) - Quality Audit Remediation
Provided Project Management, compliance, automation and qualification expertise to remediate Sonexus's quality system and verify it conforms with clients requirements. Responsibilities include reviewing current environmentally controlled storage Qualification to ensure they meet applicable CFRs and the client's requirements and assisting Sonexus in procedural changes and validation execution. All was completed on an accelerated schedule such that product could be shipped on time.
Warner Lambert, Puerto Rico - Nitrostat
Turnkey ProjectDesigned, implemented, and validated the process control and monitoring system for a pharmaceutical solid dose process and packaging line. Included Machine Interface Design, AB PLC 5 programming, AB Panelview programming, and iFix operator interface programming.
Eli Lilly, Puerto Rico - Lorabid - Process Engineering and Controls
Designed, implemented, and validated the control system hardware and software and monitoring software for a solid dose pharmaceutical packaging line. Included Machine Interface Design, AB PLC 5 programming and AB Controlview programming.
Warner Lambert, Inc., Vega Baja, Puerto Rico - Rolaids Packaging Lines Electronic Verification SystemDeveloped system specification for Rolaids Packaging Lines Electronic Verification System (RPLEVS). Design and implement electronic verification system to install barcode equipment on the Rolaids packaging lines. Includes Machine Interface Design and Interlocking, Computer Identics barcode scanners and decoder programming (4 lines).
Confidential Client Medical Products, Franklin Park, IL - Regulatory Compliance Initiative ProjectResponsible for engineering, validation and regulatory consulting to complete a compliance initiative of a syringe manufacturing facility to address internal and FDA Inspection 483 Observations. Systems included Automated Inspection, Water For Injection, Water Pretreatment, Compounding, Component Processing, Filling/Sealing, Labeling and Label Reconciliation. At the completion of the project several sessions with the FDA Inspectors were scheduled to officially close the inspection observations.
CSL Behring, IL - Biologics Processing FacilityDevelopment and Execution of Facility commissioning/qualification. Included commissioning and qualification for HVAC, Computer Control Systems, Labeling equipment, Videojet Printing systems, Laboratory equipment, Water Pretreatment, Reverse Osmosis, WFI and Pure Steam.
Ben Venue Labs, Cleveland, OH
Development of aseptic liquid filler qualifications. Included operational and performance qualification of TL/Bosch and IMA fillers for glass vials ranging from 2cc to 200cc. Drafting, execution and final report generation.
Watson Pharm, Phoenix, AZ – Laboratory/Comp Val, Policy and Procedure Development
Developed laboratory and computer systems site wide SOPS and policies. Developed and executed laboratory equipment (including HPLC, GC, FTIR) and computer system validation protocols.
North Safety Products, Providence, RI - Pharmaceutical and Medical Devices
Development and Execution of Complete Facility Validation and Compliance review. Included an Initial Phase of the Process and Facility Development of the Facility Validation Master Plan.
The Second Phase Included the Review and Development of Specifications and Development of Qualification Protocols for the Facility, HVAC, Laboratory Equipment, Purified Water System, Utilities, Label Room, Security Access System, Compressed Air and Other Systems were Developed in Phase II.
Packaging Coordinators, Inc. - Philadelphia, PA - Aseptic Syringe Line
Developed Specifications and verified Compliance for syringe components and product to be introduced in USA and Europe. Developed process Standard Operating Procedures for compounding, transferring, filling, packaging, labeling and shipping syringe product.
Batch record review and disposition for sterile injectable. Included real time analysis of calibration data, equipment setup and operation, in process testing and lab results and final batch record review.
Ben Venue Labs, Cleveland, OH - Aseptic Processing / Packaging
Development and execution of aseptic liquid filler qualifications. Included commissioning, installation and operational qualification of a fully integrated and automated Bosch Clinical Filler for glass vials ranging from 2cc to 50cc. Included 21CFR Part 11 compliance verification; audit trails, server verification, electronic batch report verification, security access rights and disaster recovery.
Bayer Corporation, NC - Sterile Fill Facility Engineering Support
Managed, designed, implemented and oversaw engineering effort on a number of projects. Including: Lyophilizer SIP cycle development and time reduction, Lyophilizer Refrigeration skid improvements, Lyophilizer auto-loader redesign, Lyophilizer piping modifications per audit, bottle rinser skid enhancements, automated glass inspection system design, stopper washer layout, installation and commissioning. Worked with Validation team during Lyophilizer OQ and PQ development and execution.
Ben Venue Labs, Cleveland - Packaging and Inspection
Development and execution of sealing and inspection system qualifications for sterile liquids. Included commissioning, installation/operational and performance qualification of Sealing Operations for glass vials ranging from 2cc to 50cc. Included Container Closure Integrity testing, 21CFR Part 11 compliance verification, security access rights and disaster recovery.
Warner Lambert, Puerto Rico - Nitrostat - Turnkey Project
Designed, implemented, and validated the process control and monitoring system for a pharmaceutical solid dose process and packaging line. Included Machine Interface Design, AB PLC 5 programming, AB Panelview programming, and iFix operator interface programming.
Eli Lilly, Puerto Rico - Lorabid - Process Engineering and Controls
Designed, implemented, and validated the control system hardware and software and monitoring software for a solid dose pharmaceutical packaging line. Included Machine Interface Design, AB PLC 5 programming and AB Control-view programming.
Aventis Behring, IL - Equipment Validation
Developed and executed equipment and controls HVAC protocols. Included specification review, field verifications and discrepancy resolution. Included Invensys and Johnson Controls systems.
Aventis Behring, IL - Biologics Processing Facility
Development and Execution of Facility Validation. Included protocols for the Computer Control Systems (PLC, PC and DCS based), Computerized Manufacturing Batching System using iBatch and iFix, Process Equipment, Laboratory Equipment, and Utilities.
Warner Lambert, Inc., Vega Baja, PR - NWDA Barcode Label Application and Scanning Project
Responsible for integration of system hardware and software for a print/apply/verify labeling process. Included Machine Interface Design, Allen-Bradley barcode scanners, Allen-Bradley PLC 5 programming, SATO barcode print engines for 6 packaging lines. System included networked operator interface stations (OITs) to allow line operators to select product and download bar code information to scanners and printers automatically. Project also included commissioning and qualification of equipment (bar code scanners, printers, OITs, network equipment) and operation of barcode printers, scanners, and packaging line reject stations.
DIAL Corporation, St. Louis, MO - Detergent – Engineering Development
Designed and implemented control system hardware, PLC software, and Operator Interface Terminal to control and monitor detergent packaging lines. Included Machine Interface Design, AB PLC 5 programming and AB Panelview programming (5 lines).
Monsanto Chemical Corporation, St. Louis, MO – Facility Design
Project design of a new facility, including equipment to manufacture chemical tablets. Responsibilities included initial cost and risk feasibility study, facility and line layouts, material flow diagrams, vendor selections and quotes and corporate presentations.
Colgate-Palmolive, Indiana - Detergent Packaging Lines Engineering Management
Designed control and line monitoring system hardware and software to control two detergent packaging lines. On-site management of engineers and contractors during startup and implementation. Included Machine Interface Design, AB PLC 5 (2 lines).
AveXis, IL –Biologic Facility Design/Build, Equipment Procurement and Qualification
Project Lead and Execution of Feasibility, Design/Build and Full Qualification for a $24MM Tech Transfer.
Phase 1 - Feasibility and Real Estate: Make/Buy Feasibility study and Property Acquisition including: Facility walk downs, Utility assessment, personnel flows, construction/demolition needs and Server Room availability.
Phase 2 – Permits & Leasing: Facility permitting, allowances for property modification, property/lease approval process, develop and submit Business/Occupancy permit and leasing agreements.
Phase 3 – VMP & Change Record Development: Validation Master Plan development, Change Record development/review and specifications in order to develop factory acceptance and site acceptance tests for ISO 5-8 equipment.
Phase 4 – User Requirements & Risk Analysis: Developing User Requirements, Risk Assessments, assessing client RFPs, vendor proposals and vendor TOPs to mitigate risk.
Phase 5 – Design & Procurement:
Phase 6 – Commissioning and Qualification: protocol generation, execution, error resolution and closeout. Systems included Facility Environmental, Clean Utilities, DCS, bioreactor, transfer lines, TFF skid, chromatography skid, aseptic filler and temperature controlled units.
Phase 7: Performance Qualification including Master Plan updates as needed, protocol generation, execution, non-conformance resolution and closeout. Testing includes: laminar flow studies, temperature distribution studies and environmental performance studies.