Validation Engineer II
Core
Drives compliance and manufacturing readiness across sterile and non-sterile operations through equipment, process, and computer system validation.
Role type
Mid-level IC Validation Engineer
Builds
Validated manufacturing systems and processes for a 503A/503B compounding pharmacy
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
validation lifecycle management, CQV activities, equipment qualification, process validation, computer system validation, regulatory compliance, change control, CAPA management, risk-based validation methodologies
Preferred skills
sterile manufacturing support, cleaning validation, sterilization validation, project management, AI-enabled analytics tools usage
Technologies
validation software, quality management systems, Microsoft Office, digital documentation platforms
Responsibilities
Develop and execute validation protocols (IQ, OQ, PQ, FAT, SAT) and reports; oversee multiple validation projects ensuring timelines and quality; support FDA regulations, cGMP, GAMP, and 21 CFR Part 11 compliance; manage change control, deviation investigations, and audit readiness; support qualification and operation of sterilization, cleaning, and lyophilization systems.
Seniority
Mid-level, hands-on IC
