Validation Engineer

We are seeking a skilled Validation Engineer with experience in aseptic process simulation, autoclaves, or cleaning validation to join our team supporting sterile injectable manufacturing operations. This role is essential in ensuring equipment, systems, and processes are qualified and compliant with regulatory standards as the facility undergoes new line installations, cycle modifications, and re?validations.

Key Responsibilities

• Generate, execute, and / or review master and completed qualification and validation protocols, summary reports, and associated data to ensure compliance with regulations, SOPs, and specifications.
• Analyze validation and testing results to determine conformance to pre?established criteria.
• Lead and support investigations, troubleshooting, and resolution of validation?related issues.
• Review, edit, and approve deviation notifications, investigations, corrective actions, change controls, SOPs, and validation documentation.
• Coordinate with cross?functional teams and external vendors to complete validation tasks efficiently.
• Execute and oversee autoclave qualifications, including load configuration and validation per PDA Technical Report concepts.
• Collect and analyze data, prepare summary reports, and present findings to management.
• Provide guidance, training, and mentorship to junior validation specialists.
• Manage project timelines and report progress to management.

Seniority level

Not Applicable

Employment type

Full?time

Job function

Pharmaceutical Manufacturing

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Rochester, NY $75,000.00-$84,000.00 2 weeks ago

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