Validation Engineer
Core
Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment and automated systems.
Role type
Validation Engineer II (Regulatory Compliance)
Builds
Validation documentation, protocols, and reports for pharmaceutical manufacturing equipment.
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Required skills
Validation documentation, FDA compliance protocols, FAT/SAT/IQ/OQ execution, QMS procedures, ICH guidelines, CFR 21 Part 211/820, investigation and troubleshooting, technical writing
Preferred skills
Pharmaceutical or medical device environment experience, automation/packaging/utilities validation experience
Technologies
Microsoft Office, Microsoft Project, AutoCAD
Responsibilities
Develop and execute validation and FDA compliance related 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 ICH/CFR guidelines; Perform investigations and troubleshoot issues related to validation; Prepare written validation reports
Seniority
Mid-level, hands-on IC
