Validation Engineer
Core
Execute validation activities for manufacturing equipment, support systems, and utilities in a large-scale mammalian cell biotech plant to ensure compliance and product quality.
Role type
Validation Engineer (Manufacturing Operations)
Builds
Commercial and clinical biopharmaceutical products
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
validation planning and execution, protocol development, performance qualification, risk-based approaches, cleaning validation, analytical and experimental design, technical writing, regulatory interpretation (GMP/CFR)
Preferred skills
GMP pharmaceutical/biotech manufacturing experience, upstream/downstream operations exposure, equipment qualification, sterilization/steaming, process understanding
Technologies
CIP, SIP, autoclave systems, airflow visualization, benchtop equipment, automation systems
Responsibilities
Develop and execute validation plans and protocols; coordinate equipment and system qualification activities; interpret engineering documentation to define validation requirements; generate and approve validation documentation; investigate technical validation issues; maintain cleaning acceptance criteria and calculate MAC; drive continuous improvement of validation programs.
Seniority
Mid-Senior level (requires 2-8+ years experience depending on education)
