Senior Engineer II, Automation, INT

About the role

Moderna is seeking an Individual to lead the design, implementation, and lifecycle management of advanced manufacturing systems supporting the production of Individualized Neoantigen Therapies (INT). This role sits at the intersection of process automation, and next-generation therapeutics, requiring both strategic thinking and hands-on technical execution. You will play a key role in scaling personalized medicine through robust, compliant, and highly integrated automation platforms.

Responsibilities

• Lead Automation Strategy & Architecture
  • Define and implement automation architectures aligned with ISA-95 (Levels 0–3) and ISA-88 standards
  • Design scalable, modular systems to support manufacturing of individualized therapy
• Own Project Delivery & Lifecycle Management
  • Lead CAPEX projects from concept through commissioning and transition into OPEX
  • Provide ongoing lifecycle support for automation systems across Moderna facilities
• Drive Cross-Functional Collaboration
  • Partner with MSAT, Manufacturing, Process Engineering, Quality, IT, Facilities, and other stakeholders to define requirements and deliver solutions
• Develop Novel and New Technologies
  • Lead the automation design for novel and new technologies
  • Oversee deployment and support of DeltaV, PLCs, SCADA, AVEVA PI, and robotics systems
  • Support Factory Acceptance Testing (FAT), commissioning, and validation activities
• Digital Integration & Data Strategy
  • Develop and maintain APIs and integrations across platforms (data lakes, WMS, ERP)
  • Enable data-driven manufacturing through connectivity and analytics-ready systems
  • Promote an AI/ML-forward mindset in system design and data utilization
• Compliance & Validation
  • Ensure adherence to 21 CFR Part 11, Annex 11, and data integrity requirements
  • Lead and support CSV (IQ/OQ/PQ) activities and risk assessments
  • Own change control processes and maintain documentation per GDP standards
• Operational Excellence
  • Identify and implement process improvements to enhance reliability, scalability, and efficiency
  • Champion continuous improvement initiatives across automation systems
  • Provide On-call and floor support
• Leadership & Mentorship
  • Provide technical leadership and mentorship to cross-functional teams
  • Support initiatives involving robotics and fleet management systems

Requirements

• Bachelor’s degree or master’s Degree in engineering plus related field or relevant experience; a combination of education and experience may be considered.
• 9 - 12 years of solid experience working in combination of manufacturing and lab systems in Pharmaceutical/Biotechnology.
• Experience with translating requirements against ISA-95 & ISA-88 structure.
• Strong automation background in DeltaV Control System including both continuous and batch processes.
• Well verse in S88 batch recipe creation, implementation, and troubleshooting.
• Well verse working with industrial protocols including HART, Ethernet I/P, OPC and classic IO.
• Hands-on experience with middleware tools (e.g., Kepware, OPC servers).
• Knowledge integrating in-line PAT systems with DCS.
• Familiarity with Robotics, PLCs, and SCADA systems.
• Experience developing RESTful APIs and system integrations.
• Experience in tech transfer processes between MSAT, Process Development, Technical Development, Process Engineering and Manufacturing.
• Strong background in CSV and regulatory compliance (21 CFR Part 11, Annex 11).
• Experience authoring, reviewing and approving FRS, URS, CDS documentation.
• Experience with IQ/OQ/PQ validation process for digital manufacturing/lab systems and with computerized system validation activities according to 21 CFR Part 11, Annex 11 and other regulatory requirements.

Qualifications

• Bachelor’s degree or master’s Degree in engineering plus related field or relevant experience; a combination of education and experience may be considered.
• 9 - 12 years of solid experience working in combination of manufacturing and lab systems in Pharmaceutical/Biotechnology.
• Experience with translating requirements against ISA-95 & ISA-88 structure.
• Strong automation background in DeltaV Control System including both continuous and batch processes.
• Well verse in S88 batch recipe creation, implementation, and troubleshooting.
• Well verse working with industrial protocols including HART, Ethernet I/P, OPC and classic IO.
• Hands-on experience with middleware tools (e.g., Kepware, OPC servers).
• Knowledge integrating in-line PAT systems with DCS.
• Familiarity with Robotics, PLCs, and SCADA systems.
• Experience developing RESTful APIs and system integrations.
• Experience in tech transfer processes between MSAT, Process Development, Technical Development, Process Engineering and Manufacturing.
• Strong background in CSV and regulatory compliance (21 CFR Part 11, Annex 11).
• Experience authoring, reviewing and approving FRS, URS, CDS documentation.
• Experience with IQ/OQ/PQ validation process for digital manufacturing/lab systems and with computerized system validation activities according to 21 CFR Part 11, Annex 11 and other regulatory requirements.

Benefits

At Moderna, we consider qualified job applicants regardless of criminal histories, consistent with legal requirements. We are 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 leavesandaccommodations@modernatx.com.

We are a smoke-free, alcohol-free, and drug-free work environment. Moderna is an E-Verify Employer in the United States. We consider qualified job applicants regardless of criminal histories, consistent with legal requirements. We are 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 leavesandaccommodations@modernatx.com.

This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

The salary range for this role is $145,900.00 - $234,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.