Job Summary: We are seeking an experienced Calibration & Maintenance Engineer to join our innovative gene therapy manufacturing team. In this critical role, you will serve as the subject matter expert for calibration, metrology, and planned maintenance activities, ensuring that our GMP assets are always ready and compliant for the production and testing of cutting-edge gene therapy products. Your expertise will be instrumental in maintaining our state-of-the-art facilities, supporting regulatory compliance, and driving continuous improvement in our maintenance and calibration processes. Key Responsibilities: 1. Calibration and Maintenance Leadership: - Develop and implement optimal strategies for the maintenance and calibration of GMP assets, leveraging your technical knowledge and cGMP best practices. - Provide technical oversight and approval for all calibration and maintenance documentation throughout the equipment lifecycle. - Coordinate and supervise maintenance and calibration activities performed by both internal teams and external vendors, ensuring alignment with our Computerized Maintenance Management System (CMMS). 2. Technical Documentation and Standards: - Create, review, and approve maintenance and calibration technical documents for new equipment introduction and ongoing management. - Author and maintain Technical Standards for calibration and maintenance in collaboration with other Calibration & Maintenance Engineers. - Contribute technical expertise to the development and revision of Service Level Agreements with third-party calibration and maintenance providers. 3. Quality Assurance and Regulatory Compliance: - Foster a culture of Inspection Readiness within the Facilities and Maintenance Engineering team. - Support and actively participate in regulatory inspections and audits, ensuring successful outcomes. - Manage quality processes including Risk Assessments, Change Controls, Corrective and Preventive Actions (CAPAs), and Deviations in accordance with the site Quality Management System. - Lead investigations and resolutions for deviations related to maintenance as-found failures. 4. Health, Safety, and Environmental (HSE) Leadership: - Demonstrate and promote high standards of health and safety behavior and practices. - Ensure timely and complete delivery of all EHS commitments. 5. Continuous Improvement: - Identify and implement process improvements in maintenance and calibration activities to enhance efficiency and effectiveness. - Stay current with industry trends, technological advancements, and regulatory changes relevant to GMP asset management in gene therapy manufacturing. 6. Team Collaboration and Communication: - Work closely with cross-functional teams to ensure seamless integration of maintenance and calibration activities with production schedules. - Provide clear and concise reports on asset status, maintenance activities, and calibration results to stakeholders at all levels of the organization. Required Skills and Qualifications: - Bachelor's degree in Engineering, preferably in Biomedical, Mechanical, or Electrical Engineering. - Minimum of 5 years of experience in calibration and maintenance engineering within a GMP environment, preferably in biopharmaceutical or gene therapy manufacturing. - Comprehensive knowledge of GMP regulations, FDA guidelines, and ISO standards related to calibration and maintenance in pharmaceutical manufacturing. - Proven expertise in metrology, calibration techniques, and planned maintenance methodologies. - Proficiency in using Computerized Maintenance Management Systems (CMMS) and other relevant software tools. - Strong analytical and problem-solving skills with the ability to troubleshoot complex equipment issues. - Excellent project management skills with the ability to manage multiple priorities effectively. - Outstanding communication skills, both written and verbal, with the ability to interact effectively with technical and non-technical stakeholders. - Demonstrated leadership in driving quality initiatives and fostering a culture of continuous improvement. - Experience in supporting regulatory inspections and audits in a GMP environment. - Ability to work flexible hours as needed to support critical maintenance activities and production schedules. Join our team and play a crucial role in maintaining the cutting-edge facilities that enable us to deliver life-changing gene therapies to patients worldwide. If you're passionate about precision, quality, and innovation in biopharmaceutical manufacturing, we want to hear from you!