Validation Engineer II
Core
Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment and processes, including process equipment, facility/utilities, and cleaning systems.
Role type
Mid-level IC validation engineer (pharmaceutical/medical device)
Builds
Validation protocols, risk assessments, qualification data, and compliance reports for capital projects
Domain
Life sciences (pharmaceuticals) + Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol development, FDA compliance documentation, risk assessment, user requirement specification, investigation and troubleshooting, project coordination, technical writing
Preferred skills
Knowledge of ICH Q7-Q11, 21 CFR Parts 210/211/11, ISPE Baseline Guides, GAMP5, ASTME2500
Technologies
Microsoft Office, Microsoft Project, AutoCAD
Responsibilities
Establish user requirement specifications for critical equipment and systems; Assess risk across system functions focusing on critical quality aspects; Develop and execute validation and FDA compliance related documents/protocols; Work with teams to perform investigations and troubleshoot validation issues; Analyze qualification data and recommend corrective actions; Prepare validation reports
Seniority
Mid-level, hands-on IC
