Overview
Senior Quality Assurance Engineer Jobs in Wisconsin, United States at CT19
Title: Senior Quality Assurance Engineer
Company: CT19
Location: Wisconsin, United States
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
- Conducting risk assessments (FMEA/PFMEA)
- 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
- Strong experience across validation (process, cleaning, equipment, etc.)
- 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
