MES Software Systems Engineer

RoslinCT US • Hopkinton, MA

3d • $65,000 - $98,000 • Onsite

About The Position

RoslinCT is seeking a talented MES Software Systems Engineer to support GxP software system enhancements, maintenance, and deployments within our growing Digital Manufacturing team. This role will involve networking with clients, vendors, and in-house personnel. The MES Software Systems Engineer will report directly to the Associate Director of Digital Manufacturing, contributing to the success of digital transformation initiatives. The position offers an exceptional salary and benefits package commensurate with the responsibilities. The MES Software Systems Engineer is responsible for supporting the implementation, maintenance, and optimization of GxP software systems with a focus on the Manufacturing Execution System (MES).

Requirements

• 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).
• 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.

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.

Benefits

• medical, dental, and vision insurance
• educational assistance
• a 401(k) program
• a variety of additional resources to help you thrive both personally and professionally

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level