Validation Engineer - Experienced
Core
Develop and execute validation protocols and FDA compliance documents for pharmaceutical equipment and automated systems.
Role type
Validation Engineer (Pharmaceutical/Medical Device)
Builds
Validation documentation, protocols, and reports for capital projects in pharma/medtech.
Domain
Pharmaceutical manufacturing and medical device regulation
Required skills
Validation protocol development, FDA compliance documentation, FAT/SAT/IQ/OQ execution, QMS procedures, stability protocols, regulatory investigations, technical writing, project management, AutoCAD, Microsoft Project
Preferred skills
Pharmaceutical or medical device environment experience, stability protocol expertise, ICH guidelines knowledge
Technologies
AutoCAD, Microsoft Office, Microsoft Project
Responsibilities
Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment; Perform FAT, SAT, IQ, and OQ documentation development and execution on Automated Systems; Assist in development and execution of QMS procedures and stability protocols; Perform investigations and troubleshoot validation issues; Prepare written validation reports.
Seniority
Mid-level, hands-on IC