Specialist, QA Validation & Engineering
Core
Provide Quality Assurance oversight for Facilities, Engineering, and Validation groups to ensure compliance with US regulations and industry standards for CGMP manufacturing of gene therapies and vaccines.
Role type
Specialist, QA Validation & Engineering
Builds
CGMP manufacturing suites, fill/finish, testing labs, and cold storage for advanced therapeutic products (AAV, viral vectors, vaccines)
Domain
Biopharmaceutical manufacturing (Gene Therapy, Viral Vectors, Vaccines)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process validation lifecycle management, deviation management, change control, risk assessment, cleaning validation review, equipment qualification review, calibration and preventive maintenance review
Preferred skills
Equipment qualification (IQ/OQ/PQ), facility and utility qualification, computerized systems validation, biologics/cell therapy/gene therapy manufacturing experience
Technologies
GMP utilities, cleanroom systems, manufacturing equipment, computerized systems
Responsibilities
Review and approve process validation lifecycle documents (VMP, PPQ protocols/reports), oversee cleaning validation programs, review deviations/investigations/CAPAs/risk assessments, approve change controls impacting validated processes, support internal and external audits, review qualification activities for equipment/facilities/utilities, approve calibration and preventive maintenance documentation
Seniority
Specialist, hands-on IC
