Sr Manager, Facilities and Engineering – Calibration

The Role

Moderna is looking a Calibration Lead to oversee the execution of the calibration program across all sites. Maintenance technician staff and will be responsible for execution of the day-to-day maintenance to maintain equipment and systems in an operational state compliant with regulatory requirements for a GMP environment. The successful candidate will be detail-oriented, organized, self-motivated, hard-working, and have a tenacity for working in a dynamic, fast-paced environment. Will lead a cohesive team responsible for maintaining laboratory equipment and instruments, ensuring compliance with cGMP 21 CFR. This role involves driving continuous improvement, managing third-party calibrations, and ensuring adherence to regulatory requirements and Moderna’s Quality System. Applicants will enjoy working in an exciting and innovative environment.

Here's What You’ll Do:

• General:

• Promote safety rules and awareness.

• Demonstrates good safety practices at all times including the appropriate use of protective equipment.

• Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) is an imperative for the business

• Work closely with other cross functional support groups

• System Management:

• Manage the calibration functions within the Maximo EAM system, ensuring accurate data entry, process flows, and system configurations.

• Calibration Expertise:

• Provide expertise in calibration methodologies, standards, and best practices. Develop and maintain calibration procedures and documentation.

• Compliance:

• Ensure all calibration activities are compliant with regulatory requirements such as ISO, FDA, or other industry-specific standards.

• Generate, revise and review cGMP documentation to ensure compliance to all applicable standards

• Support Quality Incident Investigations, CAPAs and ensure completion of assigned CAPAs completely on time.

• Drive proper cGMP documentation practices and data quality.

• Training and Support:

• Train maintenance personnel on the calibration processes within Maximo. Provide ongoing support and troubleshooting for system users.

• Data Analysis:

• Analyze calibration data to identify trends, improve processes, and ensure the integrity of measurement and testing equipment.

• Project Management:

• Lead or participate in projects related to the implementation, upgrade, or enhancement of the Maximo calibration module.

• Continuous Improvement:

• Identify opportunities for process improvements and system enhancements. Implement changes to increase efficiency and effectiveness.

• Stakeholder Communication:

• Liaise with internal stakeholders, including maintenance, quality, and IT departments, to ensure alignment of calibration activities with business objectives.

• Vendor Management:

• Coordinate with external vendors and service providers for calibration services, software support, and system integrations.

Here’s What You’ll Bring to the Table:

• Minimum BS degree or equivalent industrial or military with minimum of 10 years of relevant experience

• Experience with IBM Maximo, particularly the calibration module.

• Strong understanding of calibration principles and regulatory standards.

• Excellent project management and organizational skills.

• Proven ability to train and support end-users.

• Strong analytical and problem-solving abilities.

• Excellent communication and interpersonal skills.

• In-depth knowledge of cGMPs as they relate to facilities maintenance to ensure processes and facilities are compliant and changes are consistent with necessary controls.

• Experience with Microsoft Office Suite, RAM, Working Knowledge of cGMP for pharmaceutical manufacturing.

• Self-motivated with a drive for excellence

• Honesty, integrity, respect and courtesy with all colleagues

• Excellent written and verbal communications skills.

• Strong organizational skills and the ability to meet deadlines with minimal supervision.

• Under supervision, able to organize and present technical and project management plans, schedules and budgets.

• Strong organizational skills with the ability to manage multiple projects simultaneously.

• Excellent communication, negotiation, and stakeholder management skills.

• Proficienc