Senior Validation Engineer, Sterility & CQV
Core
Drafting, executing, and maintaining commissioning, qualification, and validation documentation for radiopharmaceutical facility, utility, analytical, laboratory, sterility assurance, and process systems in a GMP aseptic manufacturing environment.
Role type
Senior Validation Engineer (Sterility & CQV)
Builds
Validated aseptic manufacturing environments, cleanroom performance, and GMP study execution for radiopharmaceutical therapies.
Domain
Biopharmaceuticals / Radiopharmaceuticals / GMP Manufacturing
Required skills
GMP validation lifecycle management, CQV strategy development, aseptic process simulation, environmental monitoring, analytical equipment qualification, risk-based validation, deviation investigation, CAPA management, regulatory documentation drafting, cleanroom operations, radioactive material handling
Preferred skills
Process validation, cleaning validation, VHP/bio-decontamination studies, media fills, airflow visualization smoke studies
Technologies
HPLC/UPLC, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, microbiology laboratory equipment
Responsibilities
Develop and execute CQV strategies for facility and process systems; support environmental monitoring and cleanroom performance qualification; execute qualification for analytical and laboratory equipment; investigate deviations and support CAPA effectiveness; draft GMP documentation including protocols, reports, and change controls; support Health Authority inspections and audit readiness; mentor team members.
Seniority
Senior, hands-on IC