Engineering professionals in Biotechnology
Facilities, validation and capital project engineering make up most of this biotechnology group, with three of the ten at FUJIFILM Biotechnologies and others at CRISPR Therapeutics, Takeda, Ultragenyx, Replimune, EyePoint and TriLink BioTechnologies; one works on flowcell development and manufacturing engineering. Useful for decisions on GMP facility design, technology transfer, validation or scaling a process toward commercial manufacturing.
Professionals to explore
Elvin Vargas
LinkedInExperience: Head of Engineering · FUJIFILM Biotechnologies
Elvin Vargas has been Head of Engineering at FUJIFILM Biotechnologies since 2025 and was Senior Director, Automation, Engineering and CAPEX there (2023–2025). Vargas also held Director, Engineering and Technology (2019–2023), Director, Automation IT (2018–2019) and Associate Director of Automation (2014–2018) at the same company, a fit for questions on automation and capital and expense planning.
Is this you? Claim your profile and get paid for calls.
Gil Stevens
LinkedInExperience: Executive Director, Global Engineering & Capital Projects · Ultragenyx
Close to three decades at Pfizer, as Sr. Director, Engineering from 1991 to 2019, sit behind Gil Stevens' current seat as Executive Director, Global Engineering & Capital Projects at Ultragenyx since 2019. Stevens also had a Sr. Engineer role at General Dynamics Electric Boat (1985–1991), and that mix makes Stevens a fit for questions on global engineering and capital programs.
Is this you? Claim your profile and get paid for calls.
Joe Musiak
LinkedInExperience: Senior Director, Facilities & Engineering · EyePoint
GMP facility design and management is the core expertise Joe Musiak names, as Senior Director, Facilities & Engineering at EyePoint since 2022. Musiak was Senior Director Of Engineering (2019–2020) and Director of Engineering (2016–2019) at Acorda Therapeutics, Inc., and held Associate Director roles in strategic innovation and automation at Biogen (2006–2015).
Is this you? Claim your profile and get paid for calls.
John Zaremba
LinkedInExperience: Vice President of Engineering · FUJIFILM Biotechnologies
John Zaremba has been Vice President of Engineering at FUJIFILM Biotechnologies since 2025. At Regeneron, Zaremba was Senior Director (2022–2025) and Director (2018–2022) - Global Drug Product Manufacturing Sciences and Technologies, and also held Director - Technical Services at GSK (2012–2017); Zaremba names global technology transfer, GMP operations and facility design and scale-up as focus areas.
Is this you? Claim your profile and get paid for calls.
Josh Van Kirk, PE PMP
LinkedInExperience: Former Head of Engineering & Facility Operations · Takeda
Since 2025, Josh Van Kirk, PE PMP has been Head of Engineering & Facility Operations at Takeda, with Site Capital Lead Associate Director Project Engineering (2023–2025), Sr Manager Project Engineering (2021–2023), Project Engineering Manager (2019–2021) and Mgr Process Engineering (2017–2019) roles there. Van Kirk describes 20+ years in cGMP manufacturing, technology transfer and large-scale capital projects.
Is this you? Claim your profile and get paid for calls.
Kee Tsz Teresa Woo
LinkedInExperience: Director of Manufacturing Engineering · Complete Genomics
Flowcell development and R&D appear across Kee Tsz Teresa Woo's titles: Sr. Director Flowcell R&D at Sequlite Genomics/Fapon since 2023, and at Complete Genomics, Director of Manufacturing Engineering (2023), Director of Flowcell Development (2022–2023) and flowcell development manager roles from 2019 to 2022. Woo describes 10+ years developing and manufacturing consumable diagnostic devices.
Is this you? Claim your profile and get paid for calls.
Kit Erlebach
LinkedInExperience: Senior Director, Engineering and EHS · FUJIFILM Biotechnologies
Senior Director, Engineering and EHS at FUJIFILM Biotechnologies since 2023, Kit Erlebach also held Strategic and Transformational Venture Manager (2017–2023), Head of R&D Continuous Improvement (2012–2017) and Head of Technical Operations (2011–2012) roles there, plus Head of Technical Operations at Merck (2010–2011). Erlebach suits questions on combining engineering, EHS and continuous improvement at FUJIFILM Biotechnologies.
Is this you? Claim your profile and get paid for calls.
Mark Muscato
LinkedInExperience: Vice President Facilities, Engineering & Validation · Replimune
Mark Muscato has been Vice President Facilities, Engineering & Validation at Replimune since 2022, with Executive Director Facilities, Engineering & Validation (2021–2022) and Senior Director Engineering (2018–2021) roles there, and was Director - Engineering at Amgen (2011–2018). Muscato describes cGMP experience from facility design and construction to equipment and utility systems, a fit for new facility questions.
Is this you? Claim your profile and get paid for calls.
Rob Carpenter
LinkedInExperience: Former Vice President of Engineering · TriLink BioTechnologies, part of Maravai LifeSciences
Small molecule, monoclonal antibodies, vaccines, plasma and gene therapy, in bulk drug substance, drug product and fill finish, make up the 25+ years Rob Carpenter describes. Carpenter was Vice President of Engineering at TriLink BioTechnologies, part of Maravai LifeSciences (2022–2024) and Sr Director Engineering there (2021–2022), and has been Executive Consultant at MMR CONSULTING since 2024.
Is this you? Claim your profile and get paid for calls.
Sheila Boyce
LinkedInExperience: Senior Director Engineering and Validation · CRISPR Therapeutics
Scale-up of biologic and biomaterial purification processes from phase III clinical through commercialization is what Sheila Boyce describes leading over 20 years. Boyce has been Senior Director Engineering and Validation at CRISPR Therapeutics since 2022 and has held Director Engineering and Validation there since 2020, and was Senior Manager at Sarepta Therapeutics (2019–2020) and Sr. Director of Engineering at Histogenics Corporation (2014–2019).
Is this you? Claim your profile and get paid for calls.
Choose the right perspective
For facility design, utilities and validation, start with Mark Muscato, Sheila Boyce or Joe Musiak; for capital projects, Gil Stevens, Josh Van Kirk, PE PMP and Elvin Vargas. Technology transfer and drug product manufacturing questions suit John Zaremba and Rob Carpenter, EHS and continuous improvement suit Kit Erlebach, and Kee Tsz Teresa Woo covers manufacturing engineering for flowcells.
Questions to take into the conversation
- 01Which facility or utility design choices made early in a biotech build cause the most validation trouble later?
- 02What goes wrong most often when a biologics process moves from a clinical site to commercial manufacturing?
- 03How do you size and phase capital projects for a new modality when demand forecasts are still uncertain?
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot; roles marked former had ended by then. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.