Sr. Automation Engineer (Manufacturing)

The Role

As a Senior Manager of Automation at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge GxP manufacturing systems. These systems include, but are not limited to, DeltaV, Syncade, and Pi. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise in automation to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here’s What You’ll Do

In this role, your responsibilities will include:

• Taking an active lead role during the construction, CSV/CQV and overall delivery of the manufacturing facility.
• Coordinating validation activities in collaboration with Manufacturing, Engineering, Validation, and QA.
• Maintaining and sustaining a culture of compliance both in how we design solutions and in how we run and maintain operations.
• Developing and maintaining GMP system documentation and manage supporting compliance activities.
• Troubleshooting complex issues within our GxP manufacturing systems, such as DeltaV, Syncade, and Pi, ensuring their smooth and efficient operation.
• Supporting regulatory, partner and internal audits.
• Leading / overseeing investigations, CAPAs, deviations and change controls.
• Performing other administrative/managerial duties as required.
• Serving as a change agent to engage and educate the business owners on the capability and functionality of the solutions.
• Coordinating maintenance activities across different systems and teams, ensuring the continuity and quality of our manufacturing processes.

Here’s What You’ll Need (Minimum Qualifications)

• Bachelor of Science degree in Engineering, Computer Science, or a related technology discipline.
• 2+ years of experience with Emerson DeltaV DCS.
• Minimum of 7 years of experience in a similar role within the biotech or related industry.
• Strong knowledge of computer systems validation and GMP regulations.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Clear communication skills, with the ability to convey complex information in an understandable manner to various stakeholders.
• Experience in dealing with multiple projects and working in a multi-disciplinary team, managing multiple tasks/assignments with staggered due dates and deadlines.
• Demonstrated ability to make crisp decisions in a dynamic, fast-paced environment and build collaborative relationships with colleagues and business partners.
• Ability to quickly adapt and learn new skills and technologies.
• Experience supporting various digital manufacturing systems including Syncade and OSI Pi.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
• Understanding of biopharmaceutical processes and equipment.
• Proficiency in IT networking, with the ability to troubleshoot and optimize.
• Experience working in an operational GxP facility, demonstrating a strong understanding of the regulations and standards in this environment.

Le rôle

En tant que gestionnaire principal de l'automatisation chez Moderna, vous jouerez un rôle crucial dans nos opérations de fabrication, en soutenant le fonctionnement de nos systèmes de fabrication GxP de pointe. Ces systèmes comprennent, entre autres, DeltaV, Syncade et Pi. Vous serez à l'avant-garde de notre mission de fournir des thérapies à base d'ARNm aux patients du monde entier, en utilisant votre expertise en automatisation pour assurer le bon fonctionnement de nos processus de fabrication. Votre travail contribuera directement à la production de thérapies qui ont le potentiel de transformer la vie des patients.

Voici ce que vous ferez

Dans ce rôle, vos responsabilités comprendront :

• Élaborer et maintenir la documentation des systèmes BPF et gérer les activités de conformité associées.
• Soutenir les audits réglementaires, partenaires et internes.
• Agir en tant qu'agent de changement pour impliquer et former les responsables métier sur les capacités et les fonctionnalités des solutions.
• Maintenir et promouvoir une culture de conformité, tant dans la conception des solutions que dans l'exécution et la maintenance des opérations.
• Diriger/superviser les enquêtes, les CAPA, les écarts et les contrôles des changements.
• Coordonner les activités de validation en collaboration avec la fabrication, l'ingénierie, la validation et l'assurance qualité.
• Jouer un rôle de leader actif lors de la construction, de la validation CSV/CQV et de la livraison globale de l'installation de fabrication.
• Résoudre les problèmes complexes dans nos systèmes de fabrication GxP, tels que DeltaV, Syncade et Pi, en veillant à leur bon fonctionnement et à leur efficacité.
• Effectuer d'autres tâches administratives/gestionnaires selon les besoins.
• Coordonner les activités de maintenance entre différents systèmes et équipes, en veillant à la continuité et à la qualité de nos processus de fabrication.

Voici Ce Dont Vous Aurez Besoin (Qualifications Minimales)

• Plus de 2 ans d'expérience avec Emerson DeltaV DCS.
• Solide connaissance de la validation des systèmes informatiques et des réglementations BPF.
• Minimum de 7 ans d'expérience dans un rôle similaire dans le secteur de la biotechnologie ou dans une industrie connexe.
• Baccalauréat en sciences en génie, informatique ou dans une discipline technologique connexe.

Voici ce que vous apporterez (Qualifications préférées)

• Capacité à s'adapter rapidement et à apprendre de nouvelles compétences et technologies.
• Capacité démontrée à prendre des décisions claires dans un environnement dynamique et rapide, et à établir des relations de collaboration avec les collègues et les partenaires commerciaux.
• Expérience de travail dans une installation opérationnelle BPF, démontrant une solide compréhension des réglementations et des normes dans cet environnement.
• Désir de faire une différence en tant que membre d'une entreprise en pleine croissance et transformation, audacieuse, implacable, curieuse et collaborative.
• Maîtrise des réseaux informatiques, avec la capacité de résoudre les problèmes et d'optimiser les performances.
• Compréhension des processus et équipements biopharmaceutiques.
• Expérience dans la gestion de plusieurs projets et travail au sein d'une équipe multidisciplinaire, en gérant plusieurs tâches/affectations avec des échéances échelonnées.
• Expérience dans le soutien de différents systèmes de fabrication numérique, notamment Syncade et OSI Pi.
• Compétences en communication claires, avec la capacité de transmettre des informations complexes de manière compréhensible à divers intervenants.

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:

• Lifestyle Spending Accounts to create your own pathway to well-being
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Quality healthcare and insurance benefits
• Location-specific perks and extras!
• Educational resources
• Savings and investments
• Free premium access to fitness, nutrition, and mindfulness classes

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 [email protected]. (EEO/AAP Employer)

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