Project Manager Warehouse Support

JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-****

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Manager with project organization and execution experience managing budgets, schedules, and leading staff though fast paced complex projects.

Start-up experience in green field and existing facilities with plant and clean utility systems and process equipment for large and small projects ($200 million to $2 million).

Solid background in the design review, commissioning and qualification document development and execution for process equipment, utility systems, and facilities.

Domestic and international (EU) industrial Current Good Manufacturing Practices (cGMP) experience with: bulk chemical, solid dosage, parenteral, and bio-pharmaceutical applications.

Experience includes conducting audits of bulk, solid dosage, parenteral, and biologic pharmaceutical facility processes, utility systems, analytic laboratories, calibration, and maintenance programs.

Experience with large and small teams specializing in mentoring entry level team members in commissioning and qualification activity: design review, factory/site acceptance testing/ installation/operation/performance qualification protocol development, execution, and report development. PROFESSIONAL PROFILE

Project Manager

Contract to Meridian Medical Technologies Brentwood Mo. JAN 2022 TO DEC 2022

Developed Water-for-Injection system upgrades serving process formulation and clean and prep areas that will provide redundant capacity. Scope included evaluating current plant utility system capacity, identifying needed utility upgrades, developing design solutions to have minimal impact to production. Project estimated cost between

$2 and $3 million capital expenditure.

Developed Component Washer system upgrades serving clean and prep areas that will provide redundant capacity. Scope included evaluating available floor space for optimum washer location, facility structural and utility system surveys, developing design solutions that will be implemented with minimal interruption to production. Project estimated cost between $700 to $900 thousand capital expenditure. Plant Engineer

Niagara Bottling Kansas City Mo. 2021 to 2022

As the primary Niagara employee on site for the first 6 months of construction and turnover was responsible for managing the start-up of all facility-utility systems for a 620,000 square foot high speed aseptic beverage filling line including: city water, plant steam and condensate, reverse osmosis water, compressed air, nitrogen, chilled water, waste water treatment, bulk chemical storage and transfer, and fire sprinklers. Represented the company at all construction and turn over meetings. Directed contract staff in managing design solutions needed to maintain an aggressive project schedule while resolving typical start up issues. Project Manager

Contract to Boehringer-Ingleheim, St. Joseph, MO 2018 – 2021

Responsible for defining project scope, and developing budgets, and schedules or process equipment and utilities used in and animal health vaccine manufacturing environment. Developing site project management tools for tracking project progress and communicating to project stake holders and team members. Projects included JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-**** Page 2 of 10

ultralow temperature freezers, laminar air flow hoods, chemistry lab glass washers, and site safety remediation programs.

Project Manager Consulting

cGMP VALIDATION, Huntersville, NC 2016 -2018

Project Manager

Cognate Bioserrvices, Memphis, TN

Acting Validation Manager for a contract manufacturing and testing facility provider specializing in cellular therapy and gene therapy. Responsible for developing the quality program Master Plan, Standard Operating Procedures, and C&Q protocols, schedules supporting return to services for process equipment, facility, utility and quality control laboratory equipment and processes.

Merck, Desoto KS

Responsible for developing and executing client C&Q protocols for animal health production facility including process tanks, microfluidizer, temperature controlled rooms, freezers and flash freezers. EP Minerals/Aveka Processing, Fredricksburg, IA

Responsible for developing the clients quality programs, procedures, and C&Q protocols for Diatomaceous Earth purification and packaging facility process tanks, reactors, filter press, fluid bed dryers, dust collectors, dry powder handling equipment and packaging equipment.

Elanco, Lenexa, KS

Responsible for managing cGMP staff, client, and contractor staff developing and executing utility and process equipment commissioning and qualification protocols for a $20 million capital expansion for a solid dosage hormone animal health manufacturing and packaging facility.

Program included: identification of critical path systems, schedule development, FAT deficiency identification and mitigation, management of daily construction and commissioning meeting, and punch list follow up. BAYER HEALTHCARE, ANIMAL HEALTH DIVISION, Shawnee, KS 2012 - 2016 Bayer HealthCare, Animal Health Division is a US subsidiary of Bayer AG. Bayer, a global enterprise in the fields of health care and agriculture. Provided quality oversight for facility, utility, process equipment, maintenance and engineering activity.

Project Management

Developed all User Requirement Specification (URS) documents within 30 days of project kickoff by guiding the area business owners through URS and trace matrix writing for the Foot Print Optimization Project (FPOP). o Developed a standard URS template and trace matrix for identifying the stages where commissioning and qualification would confirm the URS criteria.

o Located and upgraded original URS documents for selected process equipment and utility systems. o Trained key area owners on URS and trace matrix development. o The project team drafted, reviewed and approved 30 URS documents for facilities, process equipment, and utility systems to facilitate project design in 60 days.

Plant management required all quality/engineering documents needed to support the FPOP project identified and tracked.

o Developed the project Document Matrix for tracking and management of over 340 documents needed to complete the project.

o The Microsoft Excel spreadsheet was color coded and automatically updated a statistical dash board providing management with daily progress numbers.

Area business owners did not know the capital equipment requisition process. JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-**** Page 3 of 10

o Identified the standard procurement forms and outlined the critical path for developing and approving requisitions.

o Developed scope of work, capital and expense budgets, time lines and business case justifying purchase based on return on investment.

o Preplanning and preparation resulted in the purchase over $450,000 in capital equipment while reducing the interval to process and approve a requisition from 90 to 30 days. Compliance

Coordinated document development with commissioning and qualification contractors ensuring that site standards were followed during document development and execution.

Provided preliminary review of commissioning and qualification protocols prior to approval.

Audited executed documents and reports for accuracy and consistent execution practices.

Developed and implemented qualification protocol templates in alignment with SOP-6415 (Development and Revision of Qualification Life Cycle documents).

Included user requirement specifications (URSs), design, installation, operation, performance, process, cleaning (DQ, IQ, OQ, PQ, PV, CV) protocols and reports, commissioning checklists (Cx) and reports and project validation master plans (PVMPs) and reports.

ALLISON TRANSMISSION, Speedway, IN 2009 - 2012

Largest manufacturer of automatic transmissions for trucks, buses, military vehicles, and heavy equipment. Facility engineer responsible for developing project scope, schedule and budget, vendor/contractor selection, and project management for HVAC system upgrades, machine tool coolant distribution system upgrades, and storm water systems separation and containment project for a 3.5 million square foot transmission manufacturing campus. Project Management

Plant Facilities Engineer with responsibilities that included the definition, funding, management, design, construction, and commissioning of building envelope and plant utilities needed to sustain operations.

Physical Plant Retrospective Commissioning: Developed a strategic plan and cost estimates for a retrospective commissioning of campus facility and plant utilities for a campus approaching 75 years of continuous operation.

Storm Water Separation Project: Managed $3 million in capital expenditure to separate the plant storm water system from the sanitary system and divert discharge to a local creek. Project required performing construction without interruption of campus manufacturing and public events.

Outfall Isolation Project: Managed $250,000 in capital expenditure for the installation of automated knife gate valves to isolate plant outfalls in the event of a chemical spill. Project included first use of precast concrete structures for storm water isolation.

Waste Water Treatment Plant Upgrade: Managed $500,000 in capital expenditure covering the rehabilitation of above ground waste water storage tanks to boost overall storage capacity by 50%. QUALITY VALIDATION MANAGEMENT SERVICES, Kansas City, MO 1999 - 2009 Specializes in providing Quality Management Systems Implementation, Regulatory Support, Commissioning, Qualification and Validation Services and Training Programs to pharmaceutical, biotech and medical device firms. QVM Project Manager Experience

Managed projects up to $2 million in validation services. Responsible for project schedules, budgets, deliverables, and staff for Bio-pharma validation projects in the Midwest and Northeast.

Developed and implemented in house project, technical, and regulatory training programs for new staff. Program included a two-week validation boot camp that involved the trainee in all aspects of basic utility and process equipment commissioning and qualification (C&Q) protocol development and execution.

Developed and implemented regional client identification /contact system for company business development used by local project managers. Coordinated the program with the Kansas City office to ensure prompt follow up with existing JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-**** Page 4 of 10

and new clients.

Schering-Plough Millsboro, DE

Formulation and aseptic filling equipment, air handlers, clean and plant utilities and facility C&Q.

Responsible for developing and implementing project management procedures needed to implement corporate Worldwide Quality Standards for a $20 million capital renovation to an existing poultry vaccine facility.

Program included C&Q plans, quality plans, design review, commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).

Scope included facility, utility, formulation, and filling equipment C&Q. Schering-Plough Memphis, TN

Pilot plant reverse osmosis water system replacement.

Responsible for developing and implementing project management procedures aligned with corporate Worldwide Quality Standards for small capital expansion projects.

Used scaled down programs from the previously developed large capital projects for procuring an automated reverse osmosis (RO) system for the site R&D Laboratory.

Developed and managed the execution of project C&Q plan, quality plan, design review, commissioning, FAT, and SAT.

Project met schedule and budget for the installation and start-up of the new RO system. Schering-Plough Cleveland, TN

Topical product formulation, filling and packaging equipment, process and plant utilities.

Developed and implemented project management procedures aligned with corporate Worldwide Quality Standards for an $18 million capital expansion (Spray On Suntan Lotion) project.

Program included commissioning and qualification plans, quality plans, design review, commissioning, Factory Acceptance Testing, and Site Acceptance Testing.

Scope included facility, utility, formulation, filling, and packaging equipment C&Q. Sanofi Pasteur Swiftwater, PA

Moist and dry heat gap analysis and best practices identification.

Responsible for performing best practices gap analysis for moist and dry heat sterilization (Autoclaves and Depyrogenation ovens and tunnels).

Evaluated past and current practices and developed corporate guidelines for future best practices. Afton Scientific Co Charlottesville, VA

Small scale parenteral aseptic filling facility clean utilities and shipping protocols.

Identified deliverables for small projects.

Supervised site staff and two Kansas City based staff to close out validation protocols and reports.

Developed clean utility C&Q testing protocols.

Performed system installation verification walk-downs on clean utilities.

Cross trained staff in qualification practices and field execution methods.

Supervised shipping protocol execution and data collection for small volume aseptic filling of clinical trial products shipped to the United Kingdom.

Eli Lilly and Company Indianapolis, IN

K360 Biofermentation facility.

Supervised the cold start up of the plant steam system for a new biologic pilot plant. Coordinated up to 12 contractors in teams for the tie-in of the facility plant steam distribution to the site’s main steam supply.

Developed clean steam, Water for Injection (WFI), chilled water, and compressed air system’s functional testing and operational qualification testing protocols.

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Performed system installation verification (IV) walk-downs on clean steam, WFI, chilled water, and compressed air systems.

Checked quality of vendor turnover packages for clean steam generator, WFI Still, and six Clean-In-Place (CIP) units. o Developed spreadsheets for tracking specified attributes against delivered/installed features. o Identified outstanding or deficient documentation, developed system commissioning punch lists, and tracked documentation received against requested from the vendor.

Provided technical consulting on chronic rupture disk failure at WFI heat exchanger and identified operational changes that eliminated pressure spikes that were causing the rupture disk failure. Eli Lilly and Company Indianapolis, IN

B130 Warehouse qualification review.

Managed the development and execution of the quality programs that supported a finished product warehouse.

Audited the quality review procedure of the warehouse support programs to determine the level of compliance and identified remedial action.

Reviewed the quality system components and qualification documents.

Performed Gap Analysis of SOP, calibration, preventive maintenance, change control, and records programs.

Identified action items and recommended interim and long term solutions for out of compliance conditions. Schering Plough Lincoln, NE

Animal health virus manufacturing facility.

Developed and implemented comprehensive Factory Acceptance Testing (FAT) spreadsheets that reduced execution time and identified deviation from equipment specifications. At the end of FAT execution, the client and vendor had a completed list of satisfied criteria, outstanding actions, and a clear path forward for resolution.

Managed a combined client/contractor functional specification team that developed a complete functional specification package for an integrated Bosch vial washer/tunnel/filler/capper in one week.

Developed user requirements for all process utilities and equipment associated with a vaccine pilot plant. Eli Lilly and Company Indianapolis, IN

B105 Insulin manufacturing facility design qualification.

Directed all Design Qualification activity for a $140 million plant utilities and process equipment renovation.

Supervised up to 15 staff in the development and execution of design qualification documents for process formulation, filling, clean in place equipment, autoclaves, analytical laboratory equipment, air handling systems, clean and plant utilities.

Coordinated project deliverables and requirements with client and contractors. Wyeth Vaccines Pearl River, NY

Central media-prep facility commissioning and qualification.

Supervised process utility system quality checks which included “As-Built” drawing verification, critical documentation, and testing review.

Supported project management with project quality audits.

Provided client with process design and construction design review.

Developed process utility Pro Forma documents for new automated media preparation manufacturing facility. Bayer Animal Health Shawnee KS

Hyaluronic acid process improvement-qualification.

Audited Biologic Production Batch Records identifying critical parameters for process scale-up and automation.

Developed Hyaluronic Acid Process validation protocols for new automated biologic manufacturing facility.

Supervised the execution and final report writing of Hyaluronic Acid Process Validation protocols. JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-**** Page 6 of 10

Yamanouchi/Shaklee Norman, OK

Generic solid dosage manufacturer.

Managed operating and preventive maintenance SOP development.

Reviewed/Edited C&Q protocols for process equipment and utility systems for a new solid oral dosage pharmaceutical facility.

Provided quality review of all execution documents to ensure compliance with cGMP documentation and execution practices.

Developed and implemented cGMP training programs for QVM and client staff. JACOBS ENGINEERING, Cincinnati OH/Kansas City MO/Conshohocken PA 1993 - 1999 With annual revenues exceeding $6 billion, Jacobs offers full-spectrum support to industrial, commercial, and government clients across multiple markets. Services include scientific and specialty consulting as well as all aspects of engineering and procurement, construction, and operations & maintenance. Provided commissioning and qualification project management for aseptic fill, solid dosage, non-sterile liquid and bulk API facilities, utilities and process equipment. Senior Validation Lead

Duramed Pharmaceuticals Cincinnati, OH

Solid dosage formulation, blending, compression equipment, facilities and utilities.

Project Manager responsible for all phases of project execution including: developing the master plan, identifying critical commissioning and design documentation and coordinating execution with engineering and production.

Maintained project schedule and deliverables.

Reviewed and approved process equipment and critical utility system IQ/OQ/PQ protocols.

Managed protocol review and client approval of final reports and documentation for a hormonal therapy manufacturing and packaging facility.

Bayer Animal Health Shawnee, KS

Hyaluronic acid media prep and transfer, bulk fermentation separation, filtration, and concentration.

Developed project resource time lines and Gantt charts for scheduling construction, engineering production, and validation activity.

Managed and trained 12 client and contract staff in the validation of biologic production process equipment including: Fermenters, Integrity testers, Utility Stations, Process Vessels, Ultra filtration Equipment, Bio Safety Cabinets, Freezers, and Cold Rooms.

Audited biologic production process equipment and utility system preventive maintenance, calibration, and documentation programs.

Audited process batch records, SOPs, and documentation practices.

Audited microbiology quality control laboratory records, SOPs, and documentation practices.

Evaluated biologic manufacturing process and developed process improvement solutions.

Identified improvements for batch record documentation and additional SOPs required for the manufacturing process.

Identified areas in the production and plant engineering programs requiring upgrades in cGMP compliance.

Developed process flow diagrams for the existing manufacturing process.

Identified laboratory equipment, methods, and procedures for upgrading.

Developed validation master plan and validation protocols for bulk sodium hyaluronate production.

Wrote and executed IQ/OQ/PQ Protocol for Production Fermenters. Genetics Institute Andover, MA

Bio-erodible product (BPE) manufacturing suite.

Identified and collected critical documentation of construction and commissioning practices required for protocol close out.

Provided design review for specifications, Process Flow Diagrams (PFDs) and Process and Instrumentation Diagrams JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-**** Page 7 of 10

(P&IDs) and developed procedures and commissioning documents and executed commissioning studies for Ultrasonic Washer, Depyrogenation Oven, Autoclaves, Lyophilizer, Filling Line, and Capping System, Compressed Air System, and WFI systems.

Wrote and executed C&Q protocols, summarized data and wrote final reports for: Ultrasonic Washer, Cozzoli Vial Washer, Depyrogenation Oven, Autoclaves, Lyophilizer, Filling Line, Capping System, Compressed Air System, and WFI system.

Managed the validation of pilot plant utility systems and process/filling equipment including: Ultrasonic Washer, Canister Washer, Cozzoli Vial Washer, Depyrogenation Oven, Autoclaves, Lyophilizer, Filling Line, and Capping System, Compressed Air System, and RO and WFI systems. JACOBS ENGINEERING, Dublin, Republic of Ireland 1990 - 1993 A leading contractor in Ireland, with several hundred personnel, Jacobs offers comprehensive project delivery services to the pharmaceutical, semiconductor, and petrochemical industries in Ireland and other locations worldwide Validation Supervisor

Developed marketing strategy for the combined Dublin-Cork offices, identified and contacted clients, prepared and made sales presentations, and developed proposals for C&Q projects totaling $2 million in services in less than 2 years.

Managed project schedules, budgets, and staffing for multiple projects in Ireland. Coordinated project document development and execution with Jacobs Engineering offices in Pennsylvania, Ohio, California, and Croyden UK.

Developed GMP training programs outlining the regulatory and technical requirements and methods employed in developing and executing process utilities and equipment protocols. Warner Lambert Ireland Dun Laoghaire, Dublin, Ireland Formulation equipment, ultrafiltration, aseptic filling equipment, lyophilization, packaging, equipment, facility, air handling systems, clean and process utility systems.

Project Manager responsible for co-coordinating validation activity with US/UK/Rep. of Ireland office staff, client staff, and contractors.

Developed and revised project schedules and deliverables, collected construction and commissioning documentation, initial and final protocol review and approval, and final report approval.

Provided client management and staff with daily/weekly project progress updates at operations meetings.

Provided design review for specifications, PFDs and P&IDs and developed procedures and commissioning documents and executed commissioning studies for the following systems and equipment: Purified Water System, WFI System, Clean Steam System, CIP/SIP System, Compressed Gas Systems, Lyophilizer, Depyrogenating Tunnel, and Cold Rooms.

Wrote, executed, and drafted final reports for C&Q protocols for the following systems and equipment: HVAC Systems, Purified Water System, WFI System, Clean Steam System, CIP/SIP Systems, Compressed Gas Systems, Lyophilizer, Depyrogenating Tunnel, and Cold Rooms.

Managed up to 12 execution and administrative staff for the duration of the project.

Trained client engineering staff in commissioning and start up of process utilities and equipment including: WFI and Purified Water Systems, Compressed Air, Nitrogen Systems, Lyophilizer, Depyrogenating Tunnel, and Cold Rooms.

Developed testing SOPs for non condensable and steam dryness testing and for particle monitoring equipment and biological monitoring equipment needed for execution.

Trained client microbiological staff in WFI, Purified Water, and Clean Steam System Sampling. Wyeth-Ayerst International Inc. Newbridge Kildare, Ireland Solid dosage facility greenfield site that replaced 12 existing manufacturing sites in Europe.

Project Manager responsible for identifying priorities based on critical path established for a solid dosage facility that was intended to replace 12 manufacturing sites in Europe. The position required planning and co-coordinating validation activity with client/contract staff and vendors.

Provided daily progress updates for protocol development review and approval, protocol execution, deviation JOSEPH D. KUPEC ***********@**.**.*** Cell 317-***-**** Page 8 of 10

resolution and final report close out.

Served as the client’s validation manager for the duration of the facility construction/commissioning/qualification activity.

Managed up to 20 execution and administrative staff for the duration of the project.

Supervised the transition program to successfully hand over validation, engineering records, calibration, preventive maintenance, and change control programs.

Trained client microbiological staff in water and air sampling techniques.

Trained client validation management and staff in documentation practices, document control, utility and equipment change control, training programs, and documentation practices.

Supervised the protocol execution for the following equipment and systems: RO/DI Water Systems, HVAC Systems, Dust Collection Systems, Compressed Air Systems, Tablet Presses, Ribbon Blenders, Coating Pans, Automated Systems, Milling Equipment, and Automated Coating Equipment. Barr Laboratories Dublin, Ireland

Dialysis filter manufacturing facility renovation included filter housing and filament manufacturing equipment and utilities.

Project Manager responsible for managing project schedules for the redesign and renovation of a kidney dialysis filter manufacturing facility.

Managed up to 10 engineering/validation staff for the duration of the project.

Provided design review for specifications, PFDs and P&IDs and developed procedures and commissioning documents and executed commissioning studies for the following systems and equipment: Purified Water System, WFI System, Clean Steam System, CIP/SIP System, Compressed Gas Systems, Lyophilizer, Depyrogenating Tunnel, and Cold Rooms.

Wrote, executed, and drafted final reports for IQ/OQ/PQ protocols for the following systems and equipment: HVAC Systems, Purified Water System, WFI System, Clean Steam System, CIP/SIP Systems, Compressed Gas Systems, Lyophilizer, Depyrogenating Tunnel, and Cold Rooms.

Trained client engineering staff in commissioning and start up of process utilities and equipment including: WFI and Purified Water Systems, Compressed Air, and Freon and HVAC Systems.

Directed staff in the development of operating maintenance and calibration SOPs in support of system utilities. Leo Laboratories, Kimmage Dublin, Ireland

Dermatology product formulation, filling, and packaging equipment, process and clean utilities.

Performed audits of client Validation programs and documents including change control program, calibration program, equipment history program, validation master plans, protocols, and SOPs.

Wrote and executed protocols for the following equipment and utility systems: High Speed Ointment Filling and Packaging Line, Penicillin Precipitation Vessels, USP Purified Water System, Compressed Air System, and Nitrogen System.

Irotec, Little Island Cork, Ireland

Bulk pharmaceuticals and active ingredient production facility design review.

Responsible for leading process conceptual design review to meet FDA and EU cGMPs.

Reviewed process containment designs to verify compliance with EU cGMP and Department of the Environment (IRE) guidelines.

Swords Laboratories, Swords Dublin, Ireland

Bulk pharmaceutical plant clean utility gap analysis and design review.

Developed project proposals and budget estimates for commissioning/qualification services.

Met with client engineering managers to outline the project execution plan.

Responsible for the design review, specification review, cGMP audits on existing and proposed RO/DI Water System, WFI Water System, and Clean Steam system.

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Avondale Chemical Company, Rathdrum, Wicklow, Ireland Active Pharmaceutical Ingredient manufacturing, reactors, centrifuges, fluid bed dryers, plant and clean utilities.

Maintained project document development schedule and coordinated requests for information with client and vendors.

Met with client management to review and close out executed protocols. Wrote protocol reports for client review and approval.

Audited the existing utility installation and quality programs of a bulk chemical facility for compliance with cGMPs.

Wrote and executed protocols for the following systems: HVAC Systems, Dust Collection and Extraction Systems, and Contained Waste Systems for a Bulk Chemical Process. TRIAD TECHNOLOGIES Newark DE 1989 - 1992

Bio-Pharmaceutical consulting firm supplying process development, regulatory compliance, commission and qualification services to established and emerging bio-pharmaceutical companies. Acquired by Jacobs Engineering in 1991. Wyeth Vaccines Pearl River, NY

QC laboratory dissolution equipment and utilities.

Project lead for the qualification of QC laboratory supporting tablet production.

Directed two staff in the execution of IQ/OQ protocols for tablet dissolution equipment, vacuum ovens, stability chambers, refrigerators and freezers.

Provided project manager and client with daily status update reports.

Coordinated project execution schedule with client

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