Validation & Qualification: Perform and support IQ/OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards.
Commissioning Support: Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process.
Documentation: Prepare, review, and maintain detailed validation protocols, reports, and documentation in alignment with Good Documentation Practices (GDP) and GMP regulations.
Collaboration: Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration and validation of new systems.
Regulatory Compliance: Ensure that all validation activities meet GMP regulatory requirements, contributing to the safe and compliant operation of the facility.
Troubleshooting: Identify and resolve issues that arise during the validation process, collaborating with the team to ensure all equipment operates within validated parameters.
Requirements
Experience: 4-10 years of hands-on experience in equipment validation and qualification, with a strong focus on IQ and OQ. Experience with PQ is preferred but not mandatory.
Industry Experience: Prior experience working in GMP-regulated environments is required, particularly in the pharmaceutical or biotech industries.
Equipment Knowledge: Experience with fill-finish equipment and filling lines is essential. Prior experience qualifying other types of equipment is a plus.
Commissioning Experience: Strong understanding of commissioning activities for new equipment and systems.
Documentation Skills: Proficiency in Good Documentation Practices (GDP), ensuring all validation activities are properly recorded and compliant with regulatory standards.
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