AM Technical Solutions (AM) is serving as a key partner on a new GMP facility project in the Southwest U.S. The Life Science facility will expand critical manufacturing capacity while meeting strict regulatory, scheduling, and operational requirements.
Our team is providing integrated design support, Life Sciences CQV (Commissioning, Qualification, and Validation), and project controls to help bring inspection‑ready capacity online.
To meet aggressive timelines without sacrificing quality or compliance, we are sourcing CQV leadership, process equipment expertise, and schedule professionals directly at the job site.
Working closely with the owner, construction manager, and trades, our team will help ensure that every design decision supports downstream CQV – not just first‑day turnover. Learn more about our role in this complex project.
Design Services and CQV for the New Life Science Facility
At the front end of the project, we will provide design services to support programming, concept, schematic design, and the development of key documents. Our focus is to ensure that CQV and operational readiness requirements are fully integrated into the facility design from the start – rather than bolted on late in the project when changes are costly and disruptive.
An integrated model will allow our team to carry CQV logic, risk assessments, and lifecycle quality considerations through every project phase so we can deliver on all three (cost, timeline, and quality) for the project owner.
Our dedicated project scope includes the following:
- CQV and Operations Readiness Planning: Integrated into programming, concept, schematic, and fGMP design documents.
- Design support through detailed design and construction documents: Aligning systems, equipment, and utilities with CQV URS/FRS and GMP expectations.
- Construction administration and project closeout support: Ensuring field execution, documentation, and turnover packages align with validation and inspection requirements.
- On‑site CQV Project Management, Process Equipment Lead, and Schedule Pro Lead: Providing continuous design assistance and coordination through each phase.
- Integration with project BIM requirements: Ensuring models support design coordination, fabrication, installation, and eventual operations and maintenance.
Our on‑site team will ensure that design, procurement, construction, and CQV activities stay synchronized against critical path milestones. Having personnel on-site during key project work will extend our client’s internal bandwidth while keeping a single integrated view of risk across the project.
One of the key challenges for this project is the BIM Execution Plan requires models to be maintained at specified levels, with regular uploads to a Common Data Environment (CDE) for coordination and change management. Our team will proactively ensure that these models reflect the latest design plans, so that commissioning and validation are based on accurate, field‑verified information.
By combining our Life Science project knowledge, CQV leadership, and integrated design support, we will help reduce late‑stage rework, avoid unforeseen change orders, and help our client achieve a predictable, inspection‑ready startup.
“For high‑stakes Life Science facilities, you can’t afford to separate project work into disconnected workstreams,” says Brian Williams, SVP, AM Life Sciences. “By embedding our design and CQV teams into the planning process from the start, we will be able to protect the project goals and help convert this capital program into a stable, day‑to‑day production environment.”
– Find out more about our capabilities to support high-tech construction projects in the Life Science market.
– View our portfolio of award-winning Life Science projects.
– Does your company need design development and Life Sciences CQV support for a new project? Contact us today to discuss your facility needs.