Sr Manager, Facilities and Engineering Calibration - Moderna, Inc.

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 Modernas Quality System.Applicants will enjoy working in an exciting and innovative environment.

Here's What Youll 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.

Heres What Youll 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.

• Proficiency in project management software and asset management systems.

• Knowledge of compliance and regulatory standards in the industry.

• Ability to work independently and make decisions under pressure.

• Work Environment: The role typically operates in an office environment but may require visits to various sites for asset assessment and integration. Some travel may be required.

• Additional duties as may be assigned from time to time

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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