Validation Engineer
Core
Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment and processes, including Process Equipment, Facility/Utilities, and Cleaning/Process.
Role type
Validation Engineer (Regulatory Compliance)
Builds
Validation reports, risk assessments, trace matrices, and qualification data analysis for pharmaceutical manufacturing systems.
Domain
Pharmaceutical manufacturing and regulatory compliance
Required skills
Validation protocol development, FDA compliance documentation, risk assessment, user requirement specification, investigation and troubleshooting, project planning, technical writing, data analysis
Preferred skills
Knowledge of ICH Q7-Q11, 21 CFR Parts 210/211, ISPE Baseline Guides, GAMP5, ASTME2500
Technologies
Microsoft Office, Microsoft Project, AutoCAD
Responsibilities
Establish user requirement specifications for critical equipment and systems; Assess risk across various aspects of systems' functions and focus efforts on critical quality aspects; Develop and execute validation and FDA compliance related documents/protocols; Work with teams to perform investigations and troubleshoot issues related to validation; Analyze qualification data and recommend corrective actions; Prepare validation reports; Assist in project planning, scheduling, and coordination.
Seniority
Mid-Senior level (7+ years experience)
