Sr. Automation Engineer, Drug Product Equipment Support

Moderna Therapeutics - Norwood, MA

Full-time - Mid Level

Norwood, MA

Professional, Scientific, and Technical Services

About the position

The Sr. Automation Engineer will play a pivotal role in supporting the design, development, startup, and lifecycle of a cutting-edge Drug Product (Fill Finish) cGMP manufacturing facility. Reporting to the Director, Site Digital Lead, this position requires a unique blend of technical expertise, project management skills, and the ability to collaborate across a highly matrixed organization. The successful candidate will be instrumental in the support, maintenance, and continuous improvement of the automation systems that control and monitor the facility's drug product capabilities. This role is critical in ensuring operational readiness for the production of both clinical and commercial drug products while adhering to current GxP, corporate, regulatory, and industry best practices. The Engineer will work closely with key stakeholders and original equipment manufacturers (OEM) to develop and implement the facility and equipment integration strategy. This includes ensuring that appropriate systems and operational processes are developed, implemented, and maintained to facilitate the seamless startup and routine operation of the facility. Once the facility is operational, the Sr. Automation Engineer will provide oversight for drug product operations, ensuring compliance with cGMPs, company procedures, and regulatory requirements. This position is at the forefront of delivering mRNA therapies to patients worldwide, directly contributing to the production of therapies that have the potential to transform lives. In this role, the Engineer will 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. The position also involves troubleshooting complex issues within GxP manufacturing systems, developing and maintaining automation software and hardware specifications, and leading the development of automation-related SOPs and training materials in compliance with cGMP standards. The successful candidate will manage continuous improvement projects from conception to completion, ensuring that all automation-related changes follow proper change control and validation procedures.

Responsibilities

• 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 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.

Requirements

• 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.

Nice-to-haves

• 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.

Benefits

• 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, discretionary year-end shutdown, and 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!