Technical Experts

Foster Wheeler is one of the most prestigious engineering and construction companies in the world today. As part of Foster Wheeler, we come with the backing of a four billion dollar global organization employing more than 12,000 highly skilled professionals in over 28 countries. Our industry-leading team of technical experts provide sound engineered solutions for our client's biopharm manufacturing challenges. FW Biokinetics delivers a full range of services from consultancy to the design, engineering, procurement, construction, validation and start-up of biopharmaceutical facilities worldwide. We lead the industry in the breadth and depth of process, validation and regulatory expertise enabling our customers to make a significant contribution to helping people live longer and healthier lives.

Our technical experts are considered the best-of-the-best and are frequently asked for by name, which happens to be the theme of our recent email campaign - "Put FWBiok on Speed Dial". In fact, if you click on a name below that appears in blue type (embedded link), you can view the email highlighting that individual expert. Allow us to introduce you to some of our team.

Name: Mark Canter
Title: Vice President, West Coast Operations
Experience: Mark is a mechanical engineer with over 30 years of diverse experience in the biotechnology, pharmaceutical and chemical industries. He is a recognized leader in the design and construction of large-scale bioreactors and fermentors, as well as complex modular process systems. He has extensive A/E firm and owner side experience in the scale-up and design of facilities for production of recombinant therapeutics from both bacterial and cell culture platforms, as well as blood plasma derived products.

Name: Tim Schuster
Title: Senior Bioprocess Specialist
Experience: Tim is a chemical engineer with over 25 years of extensive bioprocess engineering, project management and start-up experience, which has included the scale-up of fermentation processes, process design, large-scale cell culture, vaccines, isolation, recovery, purification, facility design, critical utility system design, and start-up and commissioning. Tim's hands-on experience in designing biopharm facilities in the U.S., Europe and Asia brings a global perspective to all his projects.

Name: Steve Goldhahn
Title: Senior Bioprocess Specialist
Experience: Steve is a chemical engineer with over 30 years of experience in process technology for the biotechnology, pharmaceutical, food, and chemical industries. He has extensive experience with cGMP-compliant unit operations including media/buffer prep/storage, cell culture and microbial-based fermentation, vaccine processes including egg-based influenza vaccine production, upstream and downstream purification operations, CIP/SIP and clean utilities. Other areas of expertise include process simulation, risk assessment, and process safety management. Steve has often been called to serve the "facilitator" role for HAZOP studies.

Name: Young Heinbockel
Title: Senior Bioprocess Specialist
Experience: Young has a graduate degree in Biotechnology and has over 18 years of biopharmaceutical experience in the design and start-up of biopharmaceutical facilities. She has been leading process design teams for the last 10 years. She has extensive experience in downstream processing, clean utilities and CIP systems. She has spent 5 years commissioning and performing operational and performance qualification of the systems that she designed or led, complimenting her process design experience. She is a hands-on technical process leader both in the office and in the field.

Name: Richard Kral
Title: Senior Bioprocess Specialist
Experience: Richard is a chemical engineer with over 30 years experience in the biopharmaceutical, refinery, chemical, and polymer industries. Richard has a particular proficiency developing overall site utility master plans for biopharm facilities. He also has substantial experience with site master planning, process development, process simulation, hydraulics, developing conceptual and detailed process packages, and designing and starting-up process facilities.

Name: Greg Hoyt
Title: Senior Bioprocess Specialist
Experience: Greg is a chemical engineer with over 19 years of experience specializing in process design, start-up, and validation of pharmaceutical and biotech facilities. He is a technical leader on projects; supervising the process, piping, and automation design and consulting for conceptual projects. He has also designed and supervised the construction and start-up of compendial water systems, bioreactors skids, CIP skids, and purification systems for chromatography and ultrafiltration. He has provided process designs for all areas of biopharm bulk manufacturing and has extensive experience with perfusion cell culture processes and equipment, aseptic processing, clean-in-place, and implementing disposables into the manufacturing process.

Name: Walt Schmid
Title: Senior Bioprocess Specialist
Experience: Walt has over two decades of experience in the process and biopharmaceutical industries including process engineering, project management, manufacturing, and facilities engineering with specific expertise in secondary manufacturing. Walt heads our Pharmaceutical Systems Group where his responsibilities include conceptual and detailed design of facilities, design and specification of process, sterile liquids filling and packaging equipment, and oral solids processing and packaging systems.

Name: Bill Beiswinger
Title: Senior Bioprocess Specialist
Experience: Bill has more than 25 years of experience in manufacturing and project engineering for the pharmaceutical and biotechnology industries. His background includes extensive experience with equipment specifications, plant layout and line arrangements, as well as hands-on installation and start-up of various pharmaceutical production lines. His project responsibility focuses on process equipment for all stages of production with particular expertise in secondary pharmaceutical manufacturing including aseptic and non-aseptic filling, and automated high speed packaging.

Name: Joe Weiss
Title: Manager of Plant Simulation
Experience: Joe is a chemical engineer with 20 years experience in process design and operations for the biotechnology, pharmaceutical, food, and chemicals industries. His focus is on improving facilities using simulation, process and facility expertise. He has worked with large and start-up clients on new and existing facilities covering a broad range of production areas. He has been involved in commercial and CMO focuses and has evaluated novel processing technologies for the biopharmaceutical industry including disposable technologies. He has given several presentations and papers on plant simulation and improving facility capabilities at a variety of conferences. He has been involved in the creation and design of multiple simulation software and has been involved in the modeling and optimization of over 50 production facilities.

Name: Christine Dell Cioppia
Title: Vice President of Validation
Experience: Chris has over 25 years of experience, specializing in qualification, validation, cGMP compliance and project management. Her extensive experience includes management of projects worldwide. Chris possesses a thorough knowledge of cGMPs, both U.S. and international, all aspects of commissioning, qualification, validation, current industry trends, as well as a solid engineering background, including eight years of experience in process and plant engineering. Chris is also experienced in bulk pharmaceuticals, biopharmaceuticals, sterile and aseptic processing, and solid oral dosage manufacturing. She has developed CQV programs for numerous clients and worked with them in the training of their personnel.

Name: Suzanna Yamamoto
Title: Director, Validation
Experience: Suzanna has over 22 years experience in the biotech, pharmaceutical and diagnostic industries that includes Validation and cGMP compliance in support of client validation activities, project management, protein purification and technology transfer. Suzanna has been providing oversight and support for Commissioning, Qualification and Validation projects for facilities, equipment and systems inclusive of clean and plant utilities, Clean-in-Place (CIP) skids, parts washers, autoclaves, media/buffer prep systems, bioreactors, ultrafiltration skids, chromatography skids, controlled temperature environments, analytical instruments, CIP, Steam-in-Place (SIP) and system revalidation. Her validation work has been successfully inspected by both the FDA and CBER.

Name: Ann Storace
Title: Principal Automation Engineer
Experience: Ann is a chemical engineer with over 21 years of experience in instrumentation and control systems engineering for the biopharmaceutical and chemical industries. Her background includes engineering responsibility for specification of instrumentation and valves including safety relief devices. She also has considerable Automation experience including generation/review of Functional Requirements Specifications, review of software implementation (Software Design Specifications), bench and field software testing, along with field commissioning for Emerson Delta V and Programmable Logic (PLC) control systems.

Name: Leo Krieg
Title: Vice President of Project Management
Experience: Leo is a chemical engineer with over 25 years of experience in the management of design, construction and validation of biopharmaceutical facilities worldwide. He is responsible for all aspects of a project's life-cycle and the supervision of engineering resources. This includes client relationship management, project personnel management, budget and cGMP compliance reviews. Scope, schedule and cost management is complemented by having participated in some of our company's most innovative product development projects including single-use process systems and advanced continuous chemical reactor and mammalian cell culture control. Leo has led the development and implementation of quality programs that resulted in ISO 9001 certification and has taken active roles in pursuit of Operational Excellence and designing for Lean Manufacturing.

Name: Paul McLaughlin
Title: Director of Project Management
Experience: Paul has more than 21 years of experience in project engineering and project management in the biopharmaceutical, food, and chemical industries. Paul has been involved in several key projects where he managed the design and construction of several biopharm manufacturing facilities. In addition, he has been involved in various campus utility upgrade projects. He provides overall supervision and program management for the engineering effort from conceptual design through detailed design, construction and start-up of facilities. Paul has a strong technical background in process piping and mechanical systems design, preconstruction, construction, procurement and start-up. As Project Manager, Paul provides an essential link between the engineering design staff and the construction, commissioning/validation staff to ensure the efficient execution of projects.

Name: Vince Ionata
Title: Senior Project Manager
Experience: Vince has over 25 years of experience in engineering and project management in the biopharmaceutical industry. He has extensive background in project execution planning, project controls, and design management. He has been responsible for directing, coordinating, and supervising all aspects of engineering projects including monitoring cost, schedule, and quality, and managing engineering, design, and procurement efforts. His experience includes leading a Project Management Office (PMO) where he was responsible for establishing project management and control guidelines and work procedures. In this role, he had oversight responsibility for multiple capital projects and client accounts. He is also responsible for coordinating the Architectural, Building Mechanical, Piping, and Electrical design disciplines for the company. Vince is a registered professional engineer in 16 states. He has published several articles for industry journals.

Name: Jay Kessler
Title: Senior Project Manager
Experience: Jay has over 40 years of design, engineering, and management experience in the pharmaceutical, chemical manufacturing, and primary metals industries. He currently manages engineering and design activities for major cGMP compliant biopharmaceutical facilities. This involves interacting with all engineering disciplines to ensure project costs and schedule goals are met, providing liaison with clients, monitoring and coordinating subcontractors and consultants, preparing critical project documentation such as action item lists and project schedules, and organizing and conducting project review meetings.

Name: Tom Moffett
Title: Principal Architect
Experience: During his 40 career, Tom has gained valuable experience in all phases of architecture including site selection, master planning, program development, conceptual design, preliminary design, construction documentation, construction support and architectural discipline management. Over the past thirty years, he has been actively involved in the design and discipline production of projects focused in the biotechnology and pharmaceutical industries. Tom has extensive experience in both national and international projects including cGMP manufacturing facilities, pilot plants, R&D facilities, vaccine production, fill/finish facilities, vivarium, BSL containment and quality testing laboratories.

Name: Michael O'Hara
Title: Facilities Design Manager
Experience: Michael has been designing projects for the biotechnology and pharmaceutical industry for over 30 years. Working with both start-ups and industry leaders he has been involved in a variety of projects including research and developments laboratories, process development and pilot plants as well as clinical and commercial cGMP manufacturing facilities. His involvement in these projects has included everything from project programming and conceptual design through detailed design and construction administration.