Validation Engineer (CQV/CSV)

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.
• • Apply risk-based validation methodologies to streamline qualification activities while maintaining quality and compliance.