Senior Validation Specialist
Core
Provide initial qualification, re-evaluation, and re-qualification support for equipment, computer systems, facilities, utilities, and processes in a biological/pharmaceutical manufacturing environment.
Role type
Senior Validation Specialist (Biological/Pharmaceutical Manufacturing)
Builds
Validated equipment, computer systems, facilities, utilities, and processes for influenza vaccine production
Domain
Biological/Pharmaceutical Manufacturing (Influenza Vaccines)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, validation lifecycle expertise, risk management, QMS understanding, technical writing, project management, cross-functional collaboration, deviation investigation, process improvement
Preferred skills
Experience with EU and FDA regulatory guidelines, leadership in validation teams, practical experience in validation function
Technologies
Computer systems, cleanrooms, cool rooms, manufacturing equipment
Responsibilities
Define validation scope, schedules, and resourcing; execute validation deliverables and programmes; document and complete validation activities; lead analysis and resolution of complex validation issues and major deviation investigations; drive validation assessments for deviations; identify and lead validation process improvements
Seniority
Senior, hands-on IC with leadership responsibilities
