Role and Responsibilities:
As a Cleaning Validation Engineer, you will be responsible for developing and executing validation strategies to ensure equipment and processes comply with domestic and international GMP regulations.
You will create and maintain validation lifecycle documentation, perform technical assessments, and collaborate with cross-functional teams to support smooth and compliant manufacturing operations.
Validation Strategy and Documentation :
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Develop comprehensive validation strategies for cleaning and sterilization processes.
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Create and maintain validation lifecycle documentation, including IQ/OQ/PQ protocols, risk assessments, traceability matrices, and validation reports.
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Review and approve validation deliverables such as project plans, protocols, reports, and test scripts.
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Lead continuous improvement initiatives in validation practices and procedures across facilities.
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Implement best practices for validation programs to ensure consistency and compliance across projects.
Technical and Quality Support:
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Provide technical assessments for CAPA, deviation, and change control management activities.
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Troubleshoot cleaning and steam sterilization issues to maintain efficient manufacturing operations.
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Support new product rollouts by validating systems and processes during Tech Transfer.
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Represent the organization in contractual and project discussions, interacting with senior internal and external stakeholders.
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Provide validation expertise to Regulatory Affairs when addressing governmental or compliance inquiries.
Cross-Functional Collaboration:
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Work closely with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to ensure all validation deliverables align with project scope and timelines.
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Collaborate to define project objectives, establish timelines, and ensure adherence to validation policies.
Required Skills:
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Bachelor’s degree in Industrial Chemical Engineering, Chemical Engineering, or a related discipline.
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Minimum 2+ years of experience in cleaning validation or related GMP manufacturing environments.
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Proven experience preparing Cleaning Validation Plans aligned with organizational policies.
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Skilled in developing and executing Cleaning Risk Assessments for new or modified product introductions based on toxicology data.
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Hands-on experience developing and executing Cleaning Validation (CV) testing protocols for CIP (Clean-in-Place) and COP (Clean-Out-of-Place) systems.
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Strong knowledge of IQ/OQ/PQ qualification protocols for autoclaves, Steam-in-Place (SIP) systems, and other GMP equipment.
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Excellent communication, documentation, and cross-functional collaboration skills.