DUANE SALTSGAVER

Cary, North Carolina *****

Phone: 949-***-**** adz8eo@r.postjobfree.com

SUMMARY

Senior Engineering Consultant / Director / Project Manager with track record of driving teams to meet operational, technical, budgeted and scheduled goals. Highly adept at capital project lifecycle management. Extensive experience in pharmaceutical, biotech, cGMP, regulated environments. Strong skills in construction management, equipment specification, Capital Expenditures, risk assessment, commissioning, validation, tech transfer, turnover and intralogistics. Broad experience including pharma/biotech design, construction, manufacturing, process, and technical writing. Expertise in:

• Project Management • Commissioning • Validations

• Vendor Management • Regulatory Compliance • Risk Assessment

• Construction Management • Design Management • Change Control Technical Skills

• Process Optimization • Aseptic Processes • Presentation / Training

• Design Engineering • Tech Transfer • Technical Troubleshooting

• Intralogistics • Acceptance Testing • Select Agent Clearance PROFESSIONAL EXPERIENCE

Hipp Design and Engineering – Raleigh, NC 7/2023 – 9/2023 Intralogistics Lead / Novo Nordisk expansion – Contractor Served as Intralogistics design lead collaborating with engineering design partners. Created Process Flow Diagrams, waste stream /ecodock management, warehouse design ASRS, AGV and AMR requirements. Dagard USA – Canton GA 2/2023 – 6/2023

Sr. Project Manager – Modular Clean Room Systems – Contractor Served as project lead on design of new vaccine manufacturing clean room systems for Moderna’s sites in Australia, United Kingdom and Canada. This included oversight of one Dagard Project Manager as well as multiple contractors such as CRB, IPS and Sisk. Abbott Laboratories – Casa Grande, AZ 8/2022– 11/2022 Consultant – Corporate Engineering – (thru Advanced Engineering Solutions / Verista) Served as Owner’s representative overseeing the decommissioning of equipment and directing demolition and construction of ~10,000 sf manufacturing area. Scope also included managing GMP containment, rerouting and installing new trench drains and leading utility tie-ins and validation. Avid Bioservices – Torrance, CA 2/2022 – 8/2022

Consultant – Project Engineering Dept. – (thru Advanced Engineering Solutions / IPS) Acted as consultant to Avid Engineering Project Engineering department leading $6.5 million renovation of their Process Development Laboratories involving upstream and downstream process development labs. This included directing architectural, mechanical, electrical, plumbing and structural contractors through design development collaborating with internal stakeholders. Project scope included tenant improvement of labs, mechanical RTU upgrades, electrical upgrades, waste neutralization system, back- up generator, switchgear, ATS and multiple bioreactor installations. DUANE SALTSGAVER PAGE 2

Bachem Americas – Torrance, CA 2021 – 2022

Sr. Engineering Director – Global Engineering

Site Engineering Director for Bachem America’s Torrance CA Peptide manufacturing facility owning and managing all engineering services and site capital expenditure budgets totaling ~$30 million annually.

• Manage a multi-disciplinary Site Engineering team along with contractors and consultants through multiple CAPEX projects including site expansions, site renovations, equipment installations and utility upgrades. Projects include R&D and QC lab expansions, Lyophilizer installations, Peptide Synthesizers, Solvent recovery and distribution system, Industrial Hygiene and Clean Room renovations, multiple HVAC and Automation upgrades. This includes overall responsibility for Basis of Design, Detail Design, Permitting, Construction, Scheduling, Equipment Installation, Commissioning, Qualification and Turnover.

• Coordinate all engineering activities with cross functional stakeholders to develop the base plan and coordinate technical requirements with engineering disciplines in order to design, develop, project and improve processes and material flows across the Bachem Torrance six building campus.

• Oversaw all Site Engineering CAPEX projects where all 2021 projects were completed on budget.

• Represent Global Engineering on the Site Leadership committee.

• Responsible for creating and maintaining Engineering Cost Center budgets, personnel and technical strategies. Also assist with Engineering oversite at our Bachem San Diego facility.

• Led a 3 month effort of Engineering team on Feasibility Study for potential of advanced Oligonucleotide manufacturing including concept summary and budgetary estimates.

• Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate. Allergan – Irvine, CA 2017 – 2020

Sr. Engineering Manager – Global Engineering

Site Engineering Manager for BioScience Laboratories Irvine (BLI) owning and managing all engineering services and site budget for Allergan’s Botox franchise clinical manufacturing facility.

• Functioned as overall Project Lead collaborating with Design / Construction on total manufacturing core renovations. This included Capital Expenditure Request preparation, proposal reviews, vendor selection, procurement, installation, commissioning of multiple new bioreactors, harvester, CIP skids, SCADA integration, downstream equipment, total renovation of all 36 clean rooms including new biosafety cabinets, autoclaves, electrical upgrades etc., all within a select agent and CDC registered space. Also led utility upgrade projects at the Campbell CA site.

• Led the design/construction of a new select agent cell bank freezer farm. This involved overseeing construction of the space, procurement, installation, SCADA integration, commissioning, validation of the room, new refrigerators, ultra low temp freezers, security systems. This project was delivered on time and within budget.

• Team lead on a new Drug Substance Operations multi-site GMP Documentation Control and Management System. This included managing the team on URS preparation, various new Enterprise platform customization, beta testing and document integration.

• Represented Global Engineering on the Site Leadership committee, the site Quality Culture team. This included monthly preparation and presentation to Corporate Steering Committee focusing on Engineering project status, budgets, schedules and collaboration with other departments. Baxter BioScience / Baxalta / Shire / Takeda - Covington, GA 2012 - 2017 Sr. Principal, Engineering – Baxalta Project Covington DUANE SALTSGAVER PAGE 3

Functioned as Lead Engineer collaborating with Flad Architects, Fluor Corporation and Turner Construction Company on design, construction and programming of Baxalta’s 1 million sf Plasma Fractionation facility in Covington, GA.

• Served as site lead /owner of Warehouse / Freezer construction, Fractionation, Aseptic Fill/Finish lines guiding Turner Construction and multiple third party vendors on construction, system and equipment procurement and installations. This included scale up and tech transfer

• System owner leading design, build, commissioning and qualification of the Automated Plasma Dispositioning System (APDS Sorting Line) bringing system in 70% under budget and months ahead of scheduled installation. This included vendor proposals, selection and procurement, budget management, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and Validation

• Led design and construction of 52,000 sf, -50 degrees C Freezer system and 30,000 sf +5 degrees C Cold Room

• Led Maintenance and Facility Departments is creating Instrument Calibration Assessments (ICA’s) for multiple Project Covington system and equipment installations

• System owner leading design, build, commissioning and qualification of seven Environmental Rooms

/ Stability Chambers

• Led design and construction of the Material Sampling Suite consisting of two Laminar Flow Hoods with entry/exit airlocks, automated conveying system and ISO 8 Clean Rooms. This included vendor selection and procurement, budget management, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and Validation.

• Authored ~50 User Requirement Specifications (URS’s), Facility Design Packages (FDP’s) and Equipment Specifications for various Project Covington systems and equipment

• Responsible for managing Change Control and Deviation aspects of multiple sub-projects across the Covington facility

Coca-Cola Company - Atlanta, GA 2011 - 2012

1 Year Project Management Consulting Contract with Coca-Cola Equipment Eng Group

• Led Process Standardization team for CAT-1 (Category 1) Refurbishment of Coca-Cola’s Cooling and Vending equipment. Served as Project Manager leading team tasked with standardizing refurbishment processes with Coke’s Make Ready Centers. These were hands on events at 21 locations across United States and Canada.

• Created Project and Communication plans, new Standards of Work and Quality Tools for Vendors and Coolers. This includes process areas such as Mechanical, Electrical, Paint, Graphics, Refrigeration and Payment systems.

• Authored Project Charters, Status Reports, Work Standards, Inspection and Auditing criteria for Coke’s CAT-1 Vending and Cooling equipment.

• Presented weekly status reports to Coke’s Executive Steering Committee (schedule, budgets, resource requirements, risks, accomplishments to date etc)

• Served as Project Lead for RoHS (Restriction of Hazardous Materials) project. This includes identifying appropriate standards and compliance, working with vendors to obtain and assure compliance, obtaining certification for components of Coke’s Vending and Cooling equipment. Videojet Technologies / Danaher Corporation - Duluth, GA 2008 – 2011 Field Engineering Manager / Sr. Project Manager - Brand Protection Solutions Group Managed pharma serialization and packaging installations. Directed efforts transitioning current product lines to comply with GAMP / FDA standards to market to pharmaceutical applications.

• Authored Validation and Commissioning templates for IMprints Line Controller suite of products to be marketed with new Pharmaceutical Packaging and Serialization (Track and Trace) sales. DUANE SALTSGAVER PAGE 4

• Led Equipment Qualification for Catalent’s Print, Verify, Reject packaging lines. (FAT, Commissioning, IQ,OQ,PQ) - within spec, on time, under budget resulting in additional sales

• Established compliance processes into Videojet’s Track and Trace products. Included 21 CFR Part 11 compliance, GAMP4, ISO standards, Version Control, Electronic Signature verification.

• Served as PM for Abbott Labs, Genentech, King Pharma and Anchen (Pharma projects involving Track and Trace / Serialization) solutions for California E-Pedigree Act in pharmaceutical packaging creating User, Functional, and Device Specs and all Equipment Qualifications

• Supported Engineering Dept with daily laboratory troubleshooting of Labeling, Conveying and Vision Inspection applications and issues for Videojet clients, Pharma Packaging /Labeling converters as well as Vision System suppliers (Cognex and LVS)

X-nth Inc. - Alpharetta, GA (office closed 2008) 2007 – 2008 Sr. Project Manager – Science and Technology sector Functioned as Project Manager directing design, construction, renovation and analysis of Pharmaceutical, Biotech, Healthcare, Institutional facilities. Daily interaction with clients, architects, contractors, internal cross geography teams. Schematic thru Design Development, Value Engineering, Fee Proposal, Contract Documentation, Commissioning and Contract Administration.

• Managed and directed Mechanical, Electrical, Plumbing and Fire Protection Engineering for $50 million renovation of QC Laboratory at Pfizer’s Research campus meeting budget and schedule.

• Represented X-nth as Primary Project Manager for 30,000sf, $12 million Vivarium renovation for Georgia Tech Translational Research Institute. Directed Mechanical, Electrical, Plumbing, Fire-Life Safety and Special Building System design, schedule, budget, permitting, equipment qualification, contractor and client relationships resulting in on time, in budget turnover of site. Wyeth Biotech - Sanford, NC 2003 - 2007

Project Engineer IV – Engineering Services Group

Managed capital site engineering, facilities, production and manufacturing systems projects.

• Represented Site Engineering as Team Leader of construction of new $58 million QC Laboratory. Liaised between Site and Corporate Engineering staffs insuring site standards, regulatory compliance, schedules, budgets, operational and technical requirements were met.

• Supervised daily activities of site Structural, Mechanical, Electrical, Plumbing, Fire contractors.

• Managed procurement, commissioning and transition of 600+ items existing and new equipment installed into new QC building labs. Authored and executed Risk and Impact Assessments, Commissioning Plans, Protocols, Test Procedures, Change Controls while managing logistics for entire relocation resulting in successful on time handover of facility.

• Managed development of PM Procedures and Documentation for HVAC, Fire Protection, and Specialty Gas Systems, Clean Steam, Feed Water, Pharmaceutical grade Compressed Air, WFI and many other building systems within newly constructed QC laboratory building.

• Directed design and installation of two new 750 HP Boilers resulting in 20% increase in steam generation of Central Utilities Building. This included Design and P&ID Review and Approvals, Installation, Commissioning, Permitting, Controls and Tie-ins to existing site utilities.

• Managed Capital Project involving design, procurement and Factory Acceptance Testing of custom 100cm Chromatography Column for use within Phase I/II Purification Department RELEVANT EXPERIENCE

BioMerieux, INC. - Durham, NC

Senior Process Engineer - Automation Technology Group Ball Corporation - Muncie, IN and Orlando, FL

Senior Project Engineer / Associate Department Manager - Proprietary Products Division DUANE SALTSGAVER PAGE 5

EDUCATION

B.S. Mechanical Engineering - Purdue University, West Lafayette, Indiana ACTIVITIES and HONORS

Member ISPE (International Society of Pharmaceutical Engineers) Member PDA (Parental Drug Association)

Member ASHRAE (American Society of Heating, Refrigeration & Air Conditioning Engineers) Received Ball Corporation’s President's Award for outstanding management contribution PATENTS

“Automatic Fill System Glass Coatings” #US 5454873

“Glass Coating Measurement Device” #US 2995533

“Viscosity Rotation Sensor” #US 2077611

Other Patents as “Co-Inventor”

References upon request

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