Sr. Automation Engineer, Drug Product Equipment Support

TheRole
Reporting to the Director, Site Digital Lead the Sr. Automation Engineer will support the design, development, startup, and lifecycle of our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role requires a blend of technical expertise, project management, and cross-functional collaboration across a highly matrixed organization to ensure seamless and efficient manufacturing operations. The successful candidate will be instrumental in support, maintenance, and continuous improvement of the automation systems that control and monitor our facility's drug product capabilities.

This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP, corporate, regulatory and industry best practices. The Engineer will liaise with key stakeholders and original equipment manufacturers (OEM) to work through the facility and equipment integration strategy in addition to ensuring the appropriate systems and operational processes are developed, implemented, and maintained to ensure the seamless start-up and routine operation of the facility.

Upon facility start-up this role will provide Automation oversight for drug product operations to ensure compliance with cGMPs, company procedures, and regulatory requirements.

The Sr. Engineer will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise 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
Serve as the Digital owner for drug product filling equipment, managing regular maintenance and updates to ensure optimal performance and compliance with cGMP standards and industry regulations.

Develop and maintain automation software and hardware specifications ensuring they meet current and future production requirements.

Serve as Automation System Owner for equipment systems and hardware.

Troubleshoot complex issues within our GxP manufacturing systems such as Allen Bradley PLCs, Siemens PLCs, AVEVA System Platform, and AVEVA Historian ensuring their smooth and efficient operation.

Skilled in reading and interpreting blueprints, diagrams, and drawings such as Process flow diagrams (PFD), Piping and Instrumentation Diagram (P&ID).

Good Knowledge of design, engineering, and safety reviews such as HAZOP and Model Review.

Develop, verify, and document mechanical and electromechanical components to fulfill design specifications.

Knowledge of electrical theories, design principles, mechanical wiring components and connections/practices for testing and verification.

Collaborate with cross-functional teams to integrate automation systems with existing facility infrastructure.

Lead the development of automation-related SOPs, training materials, and documentation in compliance with cGMP standards.

Manage continuous improvement projects from conception to completion, including budgeting, scheduling, and vendor coordination

Stay current with advancements in automation technology and make recommendations for improvements to facility operations.

Ensure proper change control and validation procedures are followed for all automation-related changes.

Provide technical training to engineering and production staff on the use of automation systems.

Support regulatory audits with coaching from subject matter experts.

May require off-hours support as part of 24/7 on-call rotation.

Here's What You'll Need (MinimumQualifications)
Bachelor of Science degree in Electrical Engineering, Chemical Engineering, Mechanical Engineering, Computer Science, or a related field.

Minimum of 5 years of experience in automation engineering within the pharmaceutical or biotechnology industry, specifically in a drug product environment.

Skilled in coding and fixing PLCs, HMIs, SCADA systems, and other industrial control systems.

Knowledgeable in different digital manufacturing systems such as MES and Historian.

In-depth knowledge of cGMP, FDA, and regulations, pharmaceutical processing, and cleanroom operations.

Excellent written and verbal communication skills, with the ability to prepare clear and concise documentation.

Strong problem-solving abilities and attention to detail.

Ability to work independently and as part of a team in a fast-paced and changing environment.

Strong leadership skills with the ability to develop and motivate a diverse team.

Excellent project management, organizational, and communication skills.

Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders.

Problem-solving mindset with a commitment to quality and safety.

Strong analytical and problem-solving skills with a focus on continuous improvement.

Ability to manage multiple projects simultaneously and meet tight deadlines.

Here's What You'll Bring to the Table (PreferredQualifications)
Computer programming and debugging skills with specific emphasis on Function Block Diagrams (FBD), Sequential Function Charts (SFC), Structured Text (ST), and Ladder Diagram (LD).

Direct experience working with Optima and IMA drug product filling lines.

Experience with Serialization/Track-and-Trace software (H2Compute).

Experience with vision systems (Cognex preferred).

Basic understanding of Emerson DeltaV, Batch management, and batch reporting.

Experience with process historians (Aveva PI Historian, Aveva Historian).

Experience with robotics (B&R, FANUC, ABB, Panasonic).

Experience with Circuit Analysis, Power Electronics, Control Systems, PCB Design, and Material Science.

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, 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 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. 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 contact the Accommodations team at ****** . (EEO/AAP Employer)
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