Senior Validation Engineer, Sterility & CQV
Core
Draft, execute, and maintain 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, sterility assurance, environmental monitoring, aseptic process simulation, cleanroom performance qualification, analytical equipment 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 smoke studies
Technologies
HPLC/UPLC, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, microbiology lab equipment
Responsibilities
Develop and implement CQV strategies for facility and process systems; execute qualification activities for laboratory and analytical equipment; support environmental monitoring programs and aseptic process simulations; investigate manufacturing and validation-related deviations; draft GMP documentation including SOPs, protocols, and reports; support Health Authority inspections and internal audits; mentor team members.
Seniority
Senior, hands-on IC