Validation Specialist

Equipment/Utility Validation Specialist
The Equipment/Utility Validation Specialist position will prepare and execute protocols, generate reports related equipment and utility validation activities for a GMP manufacturing facility.

Responsibilities include, but are not limited to:

• Generate and execute qualification and re-qualification protocols and reports, (IQ/OQ/PQ/RQ), for the validation of new and existing equipment and utilities.
• Develop acceptance criteria consistent with industry standards, manufacturer recommendations, user and functional specifications, and current Good Manufacturing Practices (cGMP).
• Generate summary reports, following Good Documentation Practices.
• Knowledge of Aseptic Process Qualifications, Room Qualifications, Environmental Monitoring
• Use Kaye AVS or Veriteq dataloggers for thermal mapping studies.
• Generate/revise Standard Operating Procedures (SOPs).
• Analyze data for adherence to acceptance criteria.
• Documentation/resolution of deviations associated with qualification studies.
• Assist with commissioning, FATs, and SATs when applicable.
• Generate technical documents such as reports, gap analyses, and risk assessments.
• Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues.
• Perform technical review of qualification documents performed by others.
• Support services to prepare for audits.

NOTE: THIS IS NOT A CSV POSITION

Job Types: Full-time, Contract

Pay: From $30.00 per hour

COVID-19 considerations:
The position is located at an NIH facility which follows all CDC guidance regarding COVID-19 precautions.

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