Andrew Burkhart Email and Phone Number

• Managed several concurrent <$500M capital projects to meet timelines while adhering to budgetary commitments• Supported design and construction of multiple >$5MM capital projects as direct report to project manager• Facilitated project scope definitions with stakeholders and generated cost estimate for capital expenditure requests• Engaged with automation, maintenance, and qualification work groups to advance project completion milestones• Authored system and user requirement specifications for preparation of IQ/OQ documentation for execution• Completed the design, competitive bidding, and procurement of key components for production center upgrade• Participated in virtual FATs and led on-site SATs with external contractors for new automated process equipment• Developed as-built P&IDs to supplement potent drug facility expansion and production center upgrade projects• Provided support to plant personnel for equipment start up while adhering to process safety and EHS requirements

• Processed and reviewed men’s and women’s urology care product complaints for FDA reportability• Communicated with sales representatives, pathology departments, and physicians to request complaint context• Performed item and lot reviews for complaint trending, NCRs, and CAPAs in accordance with ISO 13485:2016• Utilized GDP in updates of SOP documentation to increase traceability and consistency in the quality system

• Reduced unit cost of two products by 25% and lead time by 73% through identifying and eliminating waste• Implemented the process capability index to validate output production within the product specification limits• Applied the A3 Problem Solving to continuously improve and limit waste generated in the Extrusion process:- Defined and quantified the problem with waste and the impact to production capabilities- Highlighted key process variables and initiated documentation to track machine settings - Analyzed the root cause of waste generation to develop impactful countermeasures- Recommended tolerance increase of extraction speed to align with weight distribution specifications • Leveraged insight and knowledge of team members and process owners to employ meaningful changes• Aided in the installation of a new process water distribution system in accordance with site wide policies • Worked effectively across cross-functional teams to accomplish project goals in a timely and safe manner

• Completed the design and procurement of necessary components for a heat exchanger skid upgrade including:-Sizing and completing a datasheet for a new shell and tube heat exchanger-Working with equipment suppliers to size and specify new control valves-Working with internal resources to size and specify new relief valves-Successfully completing the bidding process for equipment and valves• Calculated process equipment surface area calculations to support GMP compliance• Designed layout for multiple parties in Communications Room for expanding warehouse• Practiced and adhered to safety protocols and completed necessary safety training designated by the API pilot plant• Established meaningful relationships and connections with leaders across the industry