MES Software Systems Engineer

Roslin CT US Holdings,LLC•Hopkinton, MA

48d•Onsite

About The Position

Are you ready to take your career to the next level and help lead a cutting-edge company into a bright future? We are seeking a talented MES Software Systems Engineer to support GxP software system enhancements, maintenance, and deployments within our growing Digital Manufacturing team. You will have the chance to network with clients, vendors, and in-house personnel. You will report directly to the Associate Director of Digital Manufacturing, contributing to the success of our digital transformation initiatives. We know how valuable your problem-solving and leadership skills are to our company’s success, and we offer an exceptional salary and benefits package commensurate with the responsibilities of the position. The MES Software Systems Engineer is responsible for supporting the implementation, maintenance, and optimization of our GxP software systems with a focus on our Manufacturing Execution System (MES).

Requirements

Ability to support on-site operations in Hopkinton, MA, including rotating on-call coverage as needed.
Bachelor’s degree in Engineering, Computer Science, or related technical discipline.
2+ years of experience implementing or supporting MES solutions in biotech/pharma (e.g., POMSnet, Syncade, Werum PAS-X).
Familiarity with cloud or hybrid MES deployments and data historian connectivity.
Experience or exposure to LIMS, ERP, or other automation systems.
Working knowledge of SQL, scripting, or integration tools.
Understanding of GxP system lifecycle and validation principles.
Demonstrated ability to work collaboratively in cross-functional teams within a fast-paced CDMO environment.
Eagerness to learn, adapt, and grow in a dynamic digital manufacturing landscape.
Strong organizational and analytical skills with high attention to detail.
Effective problem-solving and troubleshooting abilities.
Clear written and verbal communication skills.
Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint).

Nice To Haves

POMSnet experience preferred.

Responsibilities

Support the configuration, deployment, and maintenance of the Manufacturing Execution System (MES) to enable efficient and compliant manufacturing operations.
Collaborate with cross-functional teams to translate business and process requirements into MES functionalities and electronic batch records (EBRs).
Design, implement, and test EBR workflows and related MES configurations.
Provide day-to-day MES user support, troubleshoot issues, and document resolutions.
Participate in system validation and qualification activities, including UAT and IQ/OQ/PQ execution.
Ensure all MES activities comply with GxP, FDA 21 CFR Part 11, and data integrity requirements.
Maintain accurate system documentation, including configuration records, user guides, and training materials.
Contribute to continuous improvement initiatives to enhance digital manufacturing capabilities and system reliability.
Monitor MES performance and collaborate with IT and automation teams to ensure uptime and availability.
Stay current on industry trends, best practices, and regulatory guidance related to MES and digital manufacturing.