Equipment Validation Specialist
Core
Ensuring compliance, quality, and operational excellence across facilities through comprehensive validation activities in pharmaceutical manufacturing, laboratory operations, and quality control.
Role type
Equipment Validation Specialist
Builds
Validated equipment and systems for pharmaceutical and life sciences clients
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP and FDA regulations knowledge, IQ/OQ/PQ protocol execution, validation project management, risk assessment, gap analysis, technical writing, data analysis, problem-solving, cleanroom environment work
Preferred skills
Engineering or Life Sciences background, calibration and metrology principles, automation systems and computer system validation, quality management systems, statistical analysis, process control methods
Technologies
Microsoft Office, GAMP5, ISO standards
Responsibilities
Execute validation protocols (IQ/OQ/PQ), manage validation projects independently, perform risk assessments and gap analyses, write validation documentation, ensure compliance with industry standards
Seniority
Mid-level, hands-on IC
