Equipment Validation Engineer - 235219

Key Responsibilities:

• 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.

Qualifications:

• 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.
• Problem-Solving : Ability to troubleshoot equipment and processes during the validation phase and effectively collaborate with technical teams to resolve issues.