Cleaning Validation Engineer
We are seeking a highly skilled Cleaning Validation Engineer to join our team. As a Cleaning Validation Engineer, you will play a crucial role in ensuring the quality and safety of our life science products.
Key Responsibilities
* Validation Impact Assessments (VIA): Generate VIA to identify potential risks and opportunities for improvement.
* Change Controls: Review Change Controls to ensure compliance with regulatory requirements.
* Process Validation Plans: Develop Process Validation Plans to ensure the quality and consistency of our products.
* Cleaning Validation Plans: Create Cleaning Validation Plans to ensure the cleanliness and sanitation of our equipment and facilities.
* Documentation Updates: Update documentation impacted by changes to Cleaning Validation and Process Validation plans.
* Cleaning Technical Assessments: Conduct Cleaning Technical Assessments to identify areas for improvement.
* Process Flow Analysis: Analyze Process Flow of Products/Equipment to optimize production processes.
* Cleaning Validation Matrices: Develop and implement Cleaning Validation Matrices to ensure thorough cleaning and sanitization.
* PPQ/PV Protocols: Generate Process Performance Qualification (PPQ) and Process Validation (PV) Protocols to ensure the quality and consistency of our products.
* Protocol Execution: Execute PPQ/PV Protocol activities to ensure timely completion.
* Employee Training: Train employees on PPQ/PV Protocols to ensure understanding and compliance.
* Progress Tracking: Generate PPQ and PV Reports to track progress and identify areas for improvement.
* Review and Approval: Review and approve project Failure Mode Effect Analysis (FMEA)/Technical Assessments as required.
Requirements
* Strong Training Skills: Must have strong training skills to train employees on PPQ/PV Protocols.
* High-Quality Reporting: Ability to generate high-quality PPQ and PV Reports.
* FMEA Review: Must be able to review and approve FMEA/Technical Assessments.
* Attention to Detail: Strong attention to detail to perform cleaning validation as per Cleaning Validation Plan(s)/Protocol(s).