Senior Quality Assurance Engineer

My client are a well-funded and growing organisation within the radiopharmaceutical space and are looking for a Senior Quality Assurance Engineer to support the build of a brand new manufacturing facility. This role is tied to a first-of-its-kind production site in the US , addressing one of the most critical global shortages in medical isotopes. This is a great opportunity to step into a build-phase environment where you’ll play a key role in shaping quality and compliance from the ground up. The Role You’ll take ownership of QA and validation activities across the new facility, including: Establishing the Master Validation Plan Writing and implementing SOPs across processes, equipment, and utilities Leading process, cleaning, and equipment validation Supporting QC method validation alongside technical teams Reviewing validation data and preparing reports to support compliance Supporting supplier audits and approved vendor processes Working cross-functionally with engineering, production, and leadership teams This is a hands-on role focused on building and implementing systems , rather than maintaining existing ones. About You 5-8 years experience in Quality Assurance within a cGMP pharmaceutical manufacturing environment Good understanding of cGMP and regulatory requirements (21 CFR) Comfortable working in a manufacturing or production environment Experience in radiopharmaceuticals is a plus, but not essential #J-18808-Ljbffr CT19