Overview:
Seeking a Biopharmaceutical Validation Engineer to support commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment and integrated systems. The role requires a self-driven professional capable of authoring and executing validation documentation independently while ensuring compliance with cGMP standards and regulatory requirements.
Required Experience:
- 4+ years of CQV and CSV experience within Life Sciences / Biopharmaceutical industry
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Strong knowledge of biologics manufacturing equipment (TFF, Chromatography, Bioreactors)
- Experience with cGMP environments and 21 CFR Part 11 compliance
- Experience developing Validation Summary Reports, Deviation Reports, and Traceability Matrices
Key Responsibilities:
- Author, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for single-use and multi-use manufacturing equipment.
- Support synchronization of manufacturing equipment and automated systems to ensure compliant operations.
- Develop and maintain validation documentation in alignment with site SOPs and regulatory standards.
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- Apply risk-based validation methodologies to streamline qualification activities while maintaining quality and compliance.