Validation Engineer (Computer Systems)
Core
Ensures compliance of computerized systems and manufacturing processes in aseptic environments through validation studies, documentation, and qualification protocols.
Role type
Mid-level IC validation engineer (cGMP)
Builds
Qualified computer systems, validation protocols, and regulatory documentation for manufacturing applications
Domain
Biopharmaceutical manufacturing / Computer Systems Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, aseptic manufacturing techniques, computer system qualification (IQ/OQ/PQ), protocol development, risk assessment, deviation investigation, technical writing, regulatory agency presentation
Preferred skills
MES (EBR) experience, historian (QMIB) experience, industrial data center infrastructure knowledge, project management
Technologies
MES (EBR), Historian (QMIB), industrial data center systems
Responsibilities
Schedules and executes computer system qualifications per SOPs; Develops and updates full life cycle documents (URS, FDS, DS, risk assessments, protocols); Conducts validation studies (utility, equipment, cleaning, process, computer, new products); Participates in dry running manufacturing system applications and develops test scenarios/scripts; Authors validation master plans and project plans; Conducts deviation investigations to identify root causes and define corrective/preventative actions; Provides technical support for investigations, action plans, and change controls
Seniority
Junior to Mid-level, hands-on IC
