Senior Validation Engineer
Core
Drafting and executing commissioning, qualification, and validation (CQV) documents and protocols for a 60,000 sq. ft. GMP Radiopharmaceutical production facility, supporting the advancement from construction to clinical development and commercial operations.
Role type
Senior Validation Engineer (GMP Manufacturing)
Builds
GMP Radiopharmaceutical production facility and associated utility/process equipment
Domain
Biopharmaceuticals / Radiopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV strategy development, GMP documentation drafting, deviation investigation, CAPA management, process validation, risk management, technical writing, regulatory guideline knowledge
Preferred skills
Multi-disciplinary engineering, cleanroom operations, radioactive material handling, AI tool usage
Technologies
GMP cleanroom systems, radiopharmaceutical production equipment
Responsibilities
Develop and implement CQV strategies for GMP spaces including sterility and production areas; Support engineering, QC, and Operations teams in implementing new processes; Own and manage specific areas of validation such as process validation, CSV, and cleaning validation; Apply technical knowledge to investigate manufacturing deviations; Draft GMP documentation including SOPs, protocols, and reports; Mentor and cross-train other team members; Execute equipment and process validations.
Seniority
Senior, hands-on IC
