AddressThe Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is committed to enhancing Australia's biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia's ability to respond to future health threats efficiently. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We're inviting visionary professionals to be part of this transformative journey, making a tangible impact on global health security.
Based at our new GMP Manufacturing facility in Melbourne, Australia, reporting to the Plant Engineering Manager, this position will be responsible for the management and supervision of all calibration works on GMP/non-GMP process and support equipment. This position will also lead troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment instrumentation. This position will be the first responder to instrument and electrical equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers.
Here's What You'll Do:
Your key responsibilities will be:
Management and coordination with end-user groups of routine and non-routine calibration work orders using the computerized maintenance management system.
Specification, fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems coordination.
Developing remediation for follow-up and emergency work to support deviations, corrective actions, and related issues.
Acting as the Metrology subject matter expert for change management assessments, deviation, and CAPA management.
Developing and revising metrology procedures and approved practices.
Your responsibilities will also include:
Participation in reliability-centered calibration programs for assets under their responsibility, development of calibration budgets, spares recommendations, and quality metrics.
Participation in internal and external audits.
Management of all Calibration Standards and Buffers to ensure accuracy and ongoing compliance with calibration activities.
Maintenance of cGMP records, both paper-based and electronic.
Provision of "on-call" support on a rotating basis and response to facilities issues as needed.
Maintenance of Qualified Trainer qualifications to facilitate On Job Training (OJT) for colleagues.
Administration and performance of works safely in accordance with site EHS policy and procedures, including LOTO, working at heights, hot works, and other duties as required.
The key Moderna Mindsets you'll need to succeed in the role:
Question convention: This role requires the courage to challenge the status quo and the ingenuity to seek out new solutions to complex problems.
Act with dynamic range: You will need to exhibit flexibility in thought and action, seamlessly switching between strategic thinking and hands-on execution to drive strategy and outcomes effectively.
Here's What You'll Bring to the Table:
Bachelor of Engineering (Electrical or equivalent) is preferred.
Trade qualification - Certificate 3 Electrical and Instrumentation, preferred.
6 to 10 years relevant experience working in a regulated (cGMP preferred) environment. Experience working in sterile manufacturing is highly desirable.
Demonstrated management and proficiency in calibrating, maintaining, and troubleshooting a variety of instrumentation used in bio-pharmaceutical production. This includes temperature, pressure, flow, and analytical instruments.
Expertise in the proper storage, handling, and usage of calibration standards and buffers.
Advanced understanding of Good Manufacturing Practices (GMP): Familiarity with GMP standards, quality management system processes and regulatory standards.
Demonstrated understanding and management of regulatory requirements (TGA, FDA, EMA etc.)
Demonstrated experience in maintaining and troubleshooting instrumentation, electrical systems and equipment used throughout the facility.
Understanding of how to validate equipment and systems to ensure they are working as intended.
Knowledge of electrical safety practices in the pharmaceutical industry, including handling of hazardous materials and electrical safety.
Computerized Maintenance Management Systems (CMMS) experience to schedule and track maintenance activities.
Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.
Must have a customer service mindset. Ability to manage competing priorities is critical.
Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to find true root cause and path forward for complex problems.
Ability to identify and drive improvements to calibration tasks and strategy.
Demonstrated ability to learn new equipment/systems.
Familiarity with Excel, Word, and PowerPoint are required.
Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are 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.
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. We're 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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