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.

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.

• 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