Validation Engineer
Core
Implementing and maintaining qualification and validation strategies for equipment, facilities, cleaning, and disinfection processes in a highly digitalized and automated biopharmaceutical manufacturing environment.
Role type
Validation Engineer
Builds
Qualified and validated manufacturing facilities, equipment, and processes for vaccines and specialty care biologics
Domain
Biopharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, biopharmaceutical process knowledge, single-use technologies, risk assessment, traceability matrix creation, deviation management, root cause analysis, continuous improvement, equipment investigation, change control assessment
Preferred skills
Kneat software, autonomous guided vehicles (AGVs), cobots, cloud systems, new product introduction (NPI)
Technologies
Kneat, AGVs, cobots, cloud systems, autoclave, VHP, SIP, UV disinfection
Responsibilities
Execute qualification and validation plans, protocols, and reports; Ensure compliance with regulatory requirements and quality standards; Validate equipment cleaning and sterilization processes; Review and approve validation deliverables; Conduct periodic reviews and re-validations; Lead equipment investigations; Assess equipment during change controls
Seniority
Mid-level, hands-on IC
