Quality Engineer, QA Validation
Core
Lead validation activities for critical systems, equipment, and processes enabling the development and manufacturing of therapies in a GMP environment.
Role type
Staff Validation Engineer (QA)
Builds
Qualified facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle.
Domain
Pharmaceutical/Biotech manufacturing, GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, GAMP 5, 21 CFR Part 11, validation lifecycle documentation, risk assessments, IQ/OQ/PQ protocols, computerized system validation, data integrity, manufacturing equipment qualification, project management, technical writing
Preferred skills
Engineering/Science/Biotechnology background, mentoring validation staff
Technologies
validation tools, standard office software
Responsibilities
Develop and implement comprehensive validation strategies aligned with regulatory requirements, collaborate with cross-functional teams to ensure successful qualification of facilities and systems, serve as a technical subject matter expert during audits and investigations, mentor team members, lead multiple concurrent validation projects
Seniority
Staff, hands-on IC with mentorship responsibilities
