Senior QA Engineer - cGMP Validation in Nuclear Medicine

CT19; Wisconsin; On-site; USD 110,000 - 150,000; Full time

Job summary

CT19 is seeking a Senior Quality Assurance Engineer to lead commissioning, qualification, and validation for a first-of-a-kind nuclear medicine production facility. You will own Master Validation Plan activities, oversee C&Q across equipment, utilities and processes, and drive validation reports in a highly regulated environment.

Ideal candidates have 5+ years in QA/validation within cgmp pharma manufacturing, deep knowledge of 21 CFR and cGMP, and experience with C&Q programs.

Qualifications

• 5+ years of Quality Assurance or Validation experience within a cGMP pharmaceutical/manufacturing environment.
• Strong knowledge of 21 CFR and cGMP requirements.
• Experience establishing and executing C&Q / validation programmes.
• Understanding of regulated laboratory methods and instrumentation.
• Radiopharmaceutical experience would be highly desirable.

Responsibilities

• Establishing and executing the Master Validation Plan.
• Equipment, utility and facility C&Q activities.
• Developing Process Validation and Cleaning Validation programmes.
• Supporting QC laboratory method validation.
• Developing SOPs for qualification, requalification and revalidation.
• Leading FMEA/PFMEA and risk assessment activities.
• Software and process-control validation.
• Stability testing plans and protocols.
• Supplier audits and Approved Supplier List development.
• Reviewing validation data and producing final qualification/validation reports.
• Working with Engineering, Production, Chemistry, QC and external stakeholders.

Skills

Quality Assurance

Validation

cGMP

21 CFR

FMEA/PFMEA

Education

Bachelor's degree in Engineering, Radiochemistry, Life Sciences

Job description

CT19 is seeking a Senior Quality Assurance Engineer to lead commissioning, qualification, and validation for a first-of-a-kind nuclear medicine production facility. You will own Master Validation Plan activities, oversee C&Q across equipment, utilities and processes, and drive validation reports in a highly regulated environment.

Ideal candidates have 5+ years in QA/validation within cgmp pharma manufacturing, deep knowledge of 21 CFR and cGMP, and experience with C&Q programs.