News & Insights
VIDEO: Understanding Commissioning, Qualification & Validation (CQV)
Why this matters now
Life sciences clients face shorter timelines, more complex processes, and tighter regulatory expectations. CQV sits at the intersection of engineering, operations, and quality, and it determines how quickly a facility moves from construction to production. Owners who treat CQV as an afterthought lose schedule and confidence. Owners who plan it from the beginning protect both.
What leaders are weighing
Project teams are weighing how to align commissioning, qualification, and validation activities across owner, design, construction, and quality stakeholders. They are deciding how to leverage commissioning data for validation, how to structure risk-based approaches, and how to coordinate with system vendors and contractors. There are tradeoffs around documentation depth, schedule integration, and how to handle the inevitable surprises. Quality teams want defensible packages. Operations teams want predictable startup. Project teams want clear handoffs. CQV done well makes those goals compatible.
How Salas O’Brien is helping clients respond
Our life sciences team helps clients plan and execute CQV strategies that fit their facility, their process, and their regulatory posture. We bring engineering, commissioning, qualification, and validation expertise together so handoffs are clean and documentation tells a coherent story. We help leaders integrate CQV with project schedules and quality systems, and we help teams move from start-up to steady production with confidence. Hear Jay Tarter, Tulsa Scott, and Josh Morton talk through how CQV connects engineering and quality.
Jay Tarter
Jay Tarter specializes in regulatory compliance for the life sciences industry. He has experience as an embedded CQV resource in facilities that manufacture and package APIs, finished pharmaceuticals, biotech products, and medical devices. He helps his clients build quality into equipment systems, processes, and test methods as required to meet FDA requirements. Jay currently serves as an Associate Vice President and Validation Department Manager at Salas O’Brien. Contact him at [email protected]
Josh Morton
Josh brings over 25 years of experience in product development, clinical, and commercial cGMP biologics manufacturing across small biotech and large pharmaceutical environments. He holds a Master of Science in Biotechnology from Johns Hopkins University and has experience developing antibodies, antibody-drug-conjugates, viral vectors, vaccines, virus-like-particles and enzymes. Josh currently serves as a Senior Process Engineer at Salas O’Brien, where he supports pharmaceutical facility design, process development, equipment design and installation, and qualification. Contact him at [email protected]
Tulsa Scott
Tulsa Scott has over 35 years of experience in engineering, commissioning, qualification, and validation. Starting his career in Naval Nuclear Power, he has spent the last 25+ years in the biotech and pharmaceutical industry. He holds a Bachelor’s and Master’s degree in Electrical Engineering from Rensselaer Polytechnic Institute. Tulsa currently serves as the Director of CQV Services for Salas O’Brien, overseeing the expansion and delivery of those services to the North American market. Contact him at [email protected].