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.
The Validation Manager at our Clayton Melbourne Resilience facility will play a crucial role in managing and overseeing the site Commissioning, Qualification and Validation (CQV) program. This role ensures that systems and equipment adhere to a consistent state of compliance and operational readiness, meeting both internal and regulatory standards.
Here’s What You’ll Do:
Your key responsibilities will be:
Leading the commissioning, qualification, and validation efforts for our early phase GMP manufacturing facility.
Providing expert guidance and supervision to staff and external service providers, ensuring timelines and quality benchmarks are met.
Maintaining and improving the validated status of site facilities, utilities, equipment, and processes.
Handling and reviewing deviation investigations and ensuring compliance across manufacturing process equipment and systems.
Your responsibilities will also include:
Owning quality records related to validation activities, including Change Controls, Deviations, and CAPAs.
Presenting validation documentation during regulatory and internal audits, contributing to the responses to audit observations.
Driving continuous improvements in the GMP Validation and Change Control Programs, enhancing quality and efficiency.
Managing the daily execution of CQV scope through contractors and consultants, ensuring the validation strategy aligns with project timelines and objectives.
The key Moderna Mindsets you’ll need to succeed in the role:
Prioritize the platform: This mindset is pivotal as you will oversee broad validation processes that support the integral framework of our mRNA technology.
Act with urgency: Your role is essential to ensure rapid and compliant production capacities, reflecting the urgent need to develop and deliver therapies.
Here’s What You’ll Bring to the Table:
B.S. in Chemical or Mechanical Engineering.
Minimum of 7+ years in commissioning / qualification / validation experience in a Sterile cGMP manufacturing environment.
Proven experience leading teams; prior supervisory experience preferred.
Strong understanding of validation principles including but not limited to facilities, utilities, systems and equipment (FUSE).
Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.
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 be able to find true root cause and path forward for complex problems.
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.
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 manager.
Ability to represent Moderna’s interests, objectives and policies in a professional and responsible manner.
This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
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.
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 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. 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 or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at ***************@modernatx.com.
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