The Role

Moderna is seeking an Individual to support the implementation, optimization, and lifecycle management of process automation systems supporting Individualized Neoantigen Therapies (INT) across Moderna’s manufacturing network.

This role will help deploy and continuously improve automation platforms across both new and existing manufacturing facilities. The engineer will collaborate with cross-functional teams to deliver scalable, compliant, and integrated automation solutions that advance Moderna’s smart manufacturing initiatives and vision for lights-out manufacturing.

The ideal candidate is a hands-on, proactive automation engineer with strong technical expertise, a collaborative mindset, and a passion for learning and implementing new technologies in a fast-paced manufacturing environment.

This position is based in Moderna’s Marlborough, MA offices.

Here’s What You’ll Do

Automation Systems Implementation & Support

• Support the implementation and expansion of process automation capabilities across new and existing manufacturing facilities
• Support the development, maintenance, and improvement of DCS (DeltaV), PLCs (AB/B&R), SCADA systems, DHS (AVEVA PI), Robotics, VMware, including adoption of new technologies and future system upgrades
• Assist with troubleshooting, optimization, and lifecycle support of process automation systems
• Participate in commissioning, startup, FAT, SAT, and system deployment activities as required

Cross-Functional Collaboration

• Collaborate with Manufacturing, Facilities, MSAT, Quality, IT Infrastructure, Process Engineering, and other cross-functional teams to define business and technical requirements
• Support integration of automation systems with enterprise platforms including Operational Data Hub (ODH), Manufacturing Execution Systems (MES), VMware, and analytics environments

Standards, Platforms & Continuous Improvement

• Contribute to the implementation and maintenance of plant floor Automation Design Guidelines and standards
• Help standardize reusable automation aligned with ISA-95 and ISA-88 principles
• Identify opportunities to improve processes, equipment, systems, and infrastructure through operational excellence initiatives and implementation of AI technologies.
• Promote an AI/ML-forward mindset in system design and data utilization

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
• Provide On-call and floor support

Validation & Compliance

• Coordinate and support validation activities in collaboration with Manufacturing, Engineering, QA, and CQV teams
• Support compliance activities related to cGMP, GAMP, CSV, and regulatory requirements
• Develop and maintain automation documentation including URS, FRS, CDS, SOPs, and validation protocols
• Support risk assessments, testing activities, and changing control processes

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

• Bachelor’s degree in Engineering, Computer Science, Chemical Engineering, Electrical Engineering, or related technical discipline
• Minimum of 5–8 years of experience in pharmaceutical or biotechnology.
• Understanding of smart manufacturing and Industry 4.0 concepts, ISA-95 and ISA-88 industry standards
• Strong experience in designing and supporting Emerson DeltaV DCS process control systems including continuous and batch processes.
• Experience working with industrial protocols including HART, Ethernet I/P, OPC and classic IO.
• Hands-on experience with middleware tools (e.g., Kepware, OPC servers)
• Familiarity with PLCs, and SCADA systems, Robotics and VMware
• Understanding of RESTful APIs and system integrations
• Working knowledge of cGMP manufacturing operations and practices
• Knowledge of GAMP, Computer System Validation (CSV), and regulatory compliance requirements
• Background in CSV and regulatory compliance (21 CFR Part 11, Annex 11)
• Experience developing automation documentation including URS, FRS, CDS, and validation protocols (IQ/OQ/PQ)
• Strong troubleshooting and problem-solving skills in fast-paced manufacturing environments

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

• Being proactive and self-motivated
• Motivation to lead projects and drive initiatives to completion
• Motivation and curiosity to learn new technologies and continuously improve
• Creative, analytical