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 state for radiopharmaceutical production facilities, utilities, and analytical equipment
Domain
Biopharmaceuticals / Radiopharmaceuticals / GMP Manufacturing
Required skills
GMP validation lifecycle management, CQV principles, sterility assurance, environmental monitoring, aseptic process simulation, analytical instrumentation qualification, deviation investigation, CAPA management, change control, technical writing, risk-based validation
Preferred skills
Process validation, cleaning validation, VHP/bio-decontamination studies, media fills, airflow visualization
Technologies
HPLC/UPLC, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, microbiology lab 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 validation-related deviations and support CAPA; Draft GMP documentation including protocols, reports, and SOPs; Mentor team members on validation activities.
Seniority
Senior, hands-on IC