Stage Presentations

Presentation #1: 1:00 PM – 1:45 PM

Automation Design Considerations for a Site-Wide System Migration

Merck’s West Point, Pa., site utilizes a site-wide business-critical alarm management system built on the Siemens Apogee building automation system with a fully custom front-end operating environment which has passed its end-of- life. It functions 24/7/365 with operators responding to real-time alarms by alerting equipment owners and dispatching response personnel. The system has over 10,000 I/O encompassing traditional and OPC-based points, with physical installations in over 50 campus buildings. Merck is undertaking a multi-year upgrade to migrate this system to Rockwell Allen-Bradley hardware with an Inductive Automation Ignition operating environment. Using this project as a case study, this presentation will discuss key automation design and planning considerations. presenters will explain how to approach large-scale automation modernization projects, highlighting key design considerations and lessons learned to ensure successful project execution. The discussion will cover the requirements definition phase, system architecture, platform vetting and selection, controller and I/O deployment, logistics, commissioning, and startup. Presenters will also examine long-term system owner considerations including flexibility and available support, new installations and expansions, and an evolution outlook with a truly hardware-agnostic front- end in a computerized system landscape with shortening lifespans.

Timothy Capparella, PE

Director – Automation Engineering, Precis Engineering + Architecture

Tim Capparella, PE, leads the Precis automation team, leveraging 15+ years of U.S. and international automation engineering experience within the manufacturing, chemical, pharmaceutical, and biotechnology markets while providing design and technical project oversight. His areas of expertise include control systems migrations and upgrades, computerized systems implementation and validation, instrument specification, and controller tuning. His background on the client side informs a dual client-consultant perspective to control systems migrations, expansions, and upgrades that deliver responsive and pragmatic solutions. He holds M.S. and B.S. in Chemical Engineering degrees from Drexel University and is a member of ISPE and the International Society for Automation (ISA).

Paul Valoret

Senior Specialist, Engineering | Plant Engineering Technical Services, Merck

Paul Valoret, Senior Specialist, Engineering, is a Senior Automation Engineer with over 25 years of experience in automation engineering within the manufacturing, facilities, and pharmaceutical industries. His areas of expertise include systems integration, automation IT, PLC-based platform implementation, and alarm management. He has been involved in operations, system administration, and project execution functions throughout his career. In his current role at Merck, Valoret supports automated systems across the West Point campus. He holds a Bachelor of Science in Mechanical Engineering from Drexel University.

Presentation #2: 2:00 PM – 2:45 PM

Accelerating Speed to Market Through Early Engagement: How Upfront Collaboration Shapes GMP Facility Design and Delivery Panel

Accelerating speed to market for GMP facilities increasingly depends on decisions made long before construction begins. Early engagement among owners, designers, builders, engineers, and trade partners can significantly influence facility design, execution strategies, and overall project outcomes—particularly in complex expansions and active campus environments. This panel explores how early cross functional collaboration helps teams anticipate constraints, identify risks sooner, and make informed design choices that support efficient GMP delivery. Drawing from recent manufacturing expansions,  renovations on active campuses, and newbuild programs, panelists will share lessons learned on how early involvement of construction, engineering, and key trades influences facility design decisions, constructability, sequencing, and regulatory readiness. The discussion will examine how practices such as early procurement and constructability input, digital coordination, and thoughtful use of prefabrication—where appropriate—can improve quality, enhance safety, and support schedule certainty. Panelists will also address challenges teams encountered when early assumptions did not hold, and how those setbacks were turned into positive outcomes through adaptation and collaboration. Rather than promoting a single delivery model, this session focuses on practical   considerations teams should evaluate early in project planning, including how much influence early engagement can realistically have, where it delivers the most value, and how expectations should be calibrated. Attendees will leave with a clearer understanding of how early engagement strategies can shape GMP facility design and execution to  support speed to market while maintaining compliance and quality.

Moderator – Michael Lanasa

Associate Director of Global Quality Compliance, Merck Research Laboratories

Michael is a dynamic change agent with extensive experience in Quality, Engineering, and Operations within the Biotechnology, Pharmaceutical, and Medical Device industries. He currently serves as the Associate Director of Global Quality Compliance at Merck, where he is responsible for modernizing and streamlining legacy Quality Management Systems (QMS) and implementing digital solutions for Commissioning, Qualification, and Validation (CQV) processes and CMMS.

His expertise spans quality systems, regulatory inspections, strategic planning, plant design including design and start-up, process and equipment validations, technology transfer, and aseptic processing. He has also been instrumental in developing and revitalizing large-scale facilities’ infrastructure, processes, and technology to maximize results in the US and international sites. Michael holds a BS in Mechanical Engineering from Drexel University.

Panelists

General Contractor – Abhishek Dhawan

Executive and Life Science Core Market Leader, DPR Construction

A life sciences executive, Abhishek Dhawan provides strategic, sustainable engineering and construction solutions across life sciences and supporting industries. At DPR Construction, he leads teams of technical builders with a strong planning mindset and deep construction expertise, delivering innovative solutions from early concept through construction. His experience spans brownfield and greenfield projects, lab conversions, facility upgrades, cGMP manufacturing, and warehousing.

Abhishek oversees operations, capital programs, and business planning, helping clients meet growth targets through efficient execution, cost savings, and proactive value strategies. As a director of global integrated delivery, he has led engineering, procurement, and construction teams across the U.S. and internationally, delivering highly regulated pharmaceutical and biotech facilities. With 21 years in the industry, he holds a Master’s in Polymer Science along with Bachelor’s degrees in Chemical Engineering and Chemistry from North Carolina State University.

Design Partner – Anish Thomas

Project Manager, PM Group

Anish Thomas is a seasoned project manager with 19 years of experience leading a diverse portfolio of Capex projects in the biopharmaceutical manufacturing sector. His experience includes large-scale projects that require strategic program-level execution along with small-scale projects requiring an agile and proactive approach. Anish has delivered greenfield, brownfield, and retrofit facility projects, consistently aligning execution strategies with client needs to ensure efficiency, flexibility, and high-impact outcomes.

Trade Partner- Zachary Heilman, PE,

Account Engineer, Southland Industries

Zachary Heilman, PE is a Penn State Architectural Engineering alumni with a focus on mechanical building systems and a depth of knowledge in structural, electrical, and construction for buildings. Zak has 15 years of professional experience with architects, engineers, and construction partners on collaborative delivery projects. For the past decade, he has specialized in mechanical design and construction for technical validated environments and specialty systems: including classified rooms, process piping, ambient/cold storage, and compressed air systems. In his current role, Zak develops custom solutions for pharmaceutical owners through design-assist and design-build delivery. Zak is a firm believer that trade partners add tangible value when engaged early.

Process Equipment – Mark O’Brien

Process Procurement Manager, DPR Construction

Mark brings more than 15 years of experience in the life sciences industry, specializing in the procurement of process, clean utilities, and laboratory equipment for complex biotech, manufacturing, and research facilities. As DPR’s Process Procurement Manager and national life sciences procurement subject matter expert, he leads project teams in developing and executing equipment purchasing strategies that support critical path schedules and regulatory compliance. His work includes contract negotiation, coordination with owners and design teams, review of technical and service requirements, and oversight of the buyout and post award coordination process, all with a focus on risk mitigation and predictable project delivery.

Throughout his career, Mark has successfully managed high value, highly complex supply chains, consistently delivering results on time and within budget. He is known for a metrics driven approach that leverages performance data to reduce risk, control costs, and improve productivity while aligning stakeholder needs. A collaborative leader, Mark emphasizes clear communication and deep understanding of client priorities, recognizing that effective equipment procurement is essential to project success and requires strong partnerships across teams and disciplines. He holds a Bachelor of Science degree in Supply Chain Management and Information Systems from Penn State University.

Presentation #3: 4:00 PM – 4:45 PM

Successful Facility Retrofit: Increase Product Pipeline Capabilities with Limited impact to Existing Licensed Facility/Products

The Polaris Pilot Plant project at Johnson & Johnson’s Malvern campus involved a complex retrofit of Building 4. Select existing infrastructure was removed and replaced with single use technologies to increase facility capabilities and flexibility to support new product development and launch while limiting impact to existing licensed products/processes. This retrofit had to overcome significant space constraints and optimize facility efficiency through innovative design strategies while ensuring product quality and operator safety. Key space-saving measures included the implementation of novel workstations, flexible suite layouts (product/equipment dependent) and in-line conditioning (ILC) technology, minimizing the use and storage of premade solutions. Using a unique approach supported by detailed 3D modeling, precise equipment placement, optimized material and personnel flows/staging were achieved within a tight footprint. This allowed for the integration of new bioprocessing equipment, including bioreactors and purification systems, while repurposing existing commercial suites without increasing the overall production space footprint. The result is a highly flexible, scalable, and future-ready facility that supports advanced biotherapeutics development and accelerates time-to-market production, while ensuring licensed products can be supplied to patients. The approach used to execute this project demonstrated exceptional planning, innovative engineering, and project teamwork to maximize the working space without impacting existing equipment and operations.

Mary Carroll

Senior Design Project Director, PM Group

Mary has over 30 years of professional experience, with a dedicated focus on the life sciences sector for more than 20 years. She offers deep insight into client objectives and aligning design solutions with a project’s strategic goals. Mary’s expertise includes planning and designing environments for academic pharmaceutical research, corporate, and biotechnology facilities, with a particular strength in laboratory design. Mary is known for keeping client priorities at the forefront while guiding project teams effectively, ensuring alignment, clarity, and momentum throughout the design process

John Way

Senior Project Architect, PM Group

John is a Registered Architect with over 18 years of experience designing some of the most technically demanding facilities in the life sciences industry. He has worked on projects spanning complex cGMP manufacturing environments to cutting-edge multimodal facilities. John has guided projects through every phase of design and construction, whether navigating intricate renovations or delivering large-scale greenfield developments. He has worked with multinational pharmaceutical clients that depend on advanced precision, compliance, and execution.

Dan Kelleher

Senior Process Engineer, PM Group

Dan brings over 13 years of experience delivering complex greenfield and brownfield projects in the pharmaceutical industry, with a strong focus on front-end planning, conceptual development, and detailed design. His expertise spans critical process areas including bulk fermentation, drug substance (DS), drug product (DP) blending, and aseptic filling systems. Throughout his career, Dan has led multidisciplinary teams as a client-side technical lead, driving project execution while also supporting ongoing manufacturing through process optimization and continuous improvement initiatives.