Aseptic Manufacturing & Validation Specialist

We are seeking a highly skilled Aseptic Manufacturing & Validation Specialist to oversee sterile vial filling, lyophilization, packaging validation, and contamination control. This role will also be responsible for identifying and collaborating with vendors to procure and implement automated aseptic filling lines, ensuring a smooth transition to an automated process. The ideal candidate should have expertise in cleanroom technology, regulatory compliance and process validation. Key Responsibilities: • Execute and monitor aseptic filling operations, including sterile vial filling, lyophilization, and capping. • Ensure contamination control in cleanroom environments, adhering to strict aseptic processing guidelines. • Lead efforts to identify, evaluate, and coordinate with vendors for procuring automated aseptic filling lines. • Oversee the installation, qualification, and validation of new automated equipment and ensure its seamless integration into manufacturing. • Perform vial integrity testing, packaging validation, and sealing to maintain sterility assurance. • Conduct risk assessments and ensure compliance with global regulatory standards (GMP, US FDA, EU EMA). • Troubleshoot aseptic processing and equipment-related issues to optimize sterile manufacturing. • Maintain thorough documentation and reports for validation and regulatory audits. Preferred Qualifications: • Bachelor's/Master's degree in Biotechnology, Microbiology, Pharmaceuticals, or a related field. • Hands-on experience in aseptic processing, sterile injectables, and contamination control. • Strong knowledge of GMP, US FDA, and EU EMA regulatory guidelines. • Prior experience in vendor coordination, equipment procurement, and process automation.

INTINERI INFOSOL PRIVATE LIMITED is a company based out at Office 21, A-81, Sector 4, Noida with it's headquarters at 12, SANKAR BOSE ROAD, KOLKATA, West Bengal, India. Intineri Infosol deals in Pan India and worldwide IT/ Non-IT recruitments along with Domestic campaigns and lead generation via opt-in mediums, customised database generation, vendor call centre campaigns, bot Voice and Non-Voice, ...