Validation Engineer 1
Core
Support GMP operations and facility validation for radiopharmaceutical manufacturing, ensuring compliance during transition from construction to commercial production.
Role type
Junior Validation Engineer (GMP Manufacturing)
Builds
GMP-compliant radiopharmaceutical therapies for oncology patients
Domain
Biotechnology / Oncology / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP requirements, validation principles, risk management, technical writing, data review
Preferred skills
Radiopharmaceutical manufacturing experience, process validation, computer system validation, cleaning validation
Technologies
GMP documentation systems, validation software
Responsibilities
Draft and execute CQV documents and protocols, support commissioning and qualification activities, assist in deviation investigations and CAPA activities, draft GMP documentation including SOPs and reports, review data for validation packages, support inspection readiness
Seniority
Entry-level, hands-on IC
