Validation Engineer
Core
Develop and execute validation protocols and FDA compliance documents for pharmaceutical equipment and automated systems to support capital projects and facility development.
Role type
Validation Engineer II (Regulatory Compliance)
Builds
Validation documentation, protocols, and reports for pharmaceutical manufacturing equipment and facilities.
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol development, FAT/SAT/IQ/OQ execution, QMS procedures, regulatory compliance (CFR 21 Part 211/820, ICH Q8/Q9/Q10), CAPA/deviation management, technical writing, project management, AutoCAD
Preferred skills
CAPA/SOP authoring
Technologies
Microsoft Office, Microsoft Project, AutoCAD
Responsibilities
Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment; Perform FAT, SAT, IQ, and OQ documentation and execution on automated systems; Assist in developing and executing QMS procedures and stability protocols; Perform investigations and troubleshoot validation issues; Prepare written validation reports.
Seniority
Mid-level, hands-on IC
