Description

Cleaning Validation Engineer | North Carolina

Responsibilities:

• Hands-on experience with systems like CIP (skids), SIP, washers, vessels, tanks, COP, and manual cleaning processes.
• Develop and execute manual cleaning protocols, validation protocols, and final reports.
• Troubleshoot CIP system failures and optimize CIP/COP systems, including equipment and manual processes.
• Analyze data, present conclusions, and recommend solutions while adhering to scope, timelines, and compliance requirements.
• Generate and resolve protocol discrepancies or deviations.
• Review GxP deliverables (specifications, procedural documents, master plans, etc.).
• Train operations staff on protocols and technical details.
• Organize and track validation activities to meet project timelines.
• Apply different sampling techniques with strong knowledge of cGMP requirements.

Qualifications:

• Engineering Degree required.
• Working knowledge of FDA and cGMP regulations.
• Proven ability to review, interpret, and draw scientific conclusions from data.
• Strong problem-solving, decision-making, and technical writing skills.
• Hands-on validation execution experience in a cGMP environment.
• Excellent communication skills and ability to collaborate effectively within a team.