Validation Engineer I
Core
Lead the development and implementation of validation strategy for biopharmaceutical manufacturing processes, equipment, and cleaning/sterilization at a manufacturing facility.
Role type
Validation Engineer I (Manufacturing Operations)
Builds
Validated manufacturing equipment, cleaning/sterilization processes, and regulatory-compliant production systems for biologics.
Domain
Biopharmaceutical manufacturing (Oncology, Inflammation, General Medicine, Rare Disease)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (validated equipment and processes)
Required skills
Equipment qualification, cleaning validation, validation maintenance, GMP compliance, regulatory filing support, root cause analysis, SOP development, project management, technical writing, cross-functional collaboration
Preferred skills
Mammalian cell culture, protein purification, clean utilities, CIP/SIP, controlled temperature chambers, Kneat/CDOCs/LIMS/Pi proficiency, Eudralex Annex 15/FDA 21 CFR knowledge
Technologies
Kneat, CDOCs, Laboratory Inventory Management System, Pi
Responsibilities
Develop validation master plans and protocols, conduct performance qualification for autoclaves and parts washers, support regulatory inspections and filings, troubleshoot process systems, lead corrective/preventive actions, and maintain validation status monitoring.
Seniority
Mid-level IC (2-8 years experience depending on degree)
