Overview
Skills
Job Details
Title: OT/IT Engineer
Regulatory Relevance: GxP, GMP
The Role: The OT/IT Engineer will collaborate with the Digital team to manage the
hardware and software systems that control and monitor cGMP manufacturing
operations. This role ensures that all manufacturing activities are supported by
reliable digital systems and are aligned with company policies and regulatory
standards to enable timely and complete product delivery.
Key Responsibilities: Manage, upgrade, and maintain Operations Technology (OT)
systems Ensure cybersecurity compliance for OT systems in alignment with
Moderna s policies Deploy and manage virtual servers within a VMware
environment Install, configure, and maintain digital manufacturing systems,
including but not limited to: COGNITE, Emerson DeltaV, ThinManager, AVEVA PI, PTC
Kepware, and FactoryTalk AssetCentre (FTAC) Provide support for system
commissioning and startup Draft technical engineering documentation such as
Functional Requirements Specifications (FRS), Configuration Design Specifications
(CDS), and configuration manuals Contribute to the development of validation
documentation including SOPs and work instructions Support system integrations
between Process Control Systems (PCS) and other platforms such as MES, PI, and
PLCs Report on project status, timelines, and deliverables Collaborate with
cross-functional teams, including MES, Validation, Process Engineering, and Quality
Provide on-site support for process equipment and digital infrastructure.
Required Background: Education: o Bachelor s degree in Computer Science,
Information Technology, Engineering, or a related field Experience: o Minimum 4
years of experience managing digital manufacturing systems (as listed above) o
Working knowledge of Python for scripting and automation tasks o Basic
understanding of regulatory and compliance standards (e.g., GMP, GxP) o
Experience with commissioning and validation in a regulated manufacturing
environment is a plus. Specific Certifications or Training: o Certification in GxP
compliance or related areas preferred. Training in GMP regulations and standard.