Staftonic LLC is hiring: Senior Cleaning Validation Engineer in Jersey City

Overview

Role: SR. Cleaning Validation Engineer

Location: Jersey City, NJ

Key Responsibilities

• Lead the development, execution, and reporting of cleaning validation protocols for manufacturing equipment.
• Design and perform vessel and equipment mapping studies to justify sampling sites.
• Develop, optimize, and validate CIP/SIP processes; author related SOPs and reports.
• Apply risk management (e.g., FMEA) to focus validation efforts on critical parameters.
• Establish scientifically sound acceptance criteria using health-based exposure limits (ADE/PDE).
• Manage cleaning validation projects from start to finish, ensuring they are on time and within budget.
• Act as the cleaning validation SME during internal audits and regulatory inspections (FDA, EMA).
• Investigate and resolve cleaning deviations, OOS results, and change control events.
• Train and mentor junior validation personnel.

Requirements

• Bachelor\'s in Life Sciences or Engineering.
• 7+ years in pharma/biologics cleaning validation.
• Must have expert-level vessel mapping and CIP/SIP experience.
• Strong knowledge of FDA/EMA regulations and analytical methods (HPLC, TOC).