Job Description

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The 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).

How You Will Make an Impact:

Are you ready to take your career to the next level and help lead a cutting-edge company into a bright future? We are actively seeking a talented Software Systems Engineer to support GxP software system enhancements, maintenance, and deployments. You will have the chance to network with clients, vendors, and in-house personnel. 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.

What You Will Bring:

• Assist in the configuration, deployment, and support of MES software to ensure efficient manufacturing operations.
• Collaborate with cross-functional teams to translate business requirements into system functionalities.
• Support the design and implementation of electronic batch records (EBRs) and workflows in the MES.
• Troubleshoot MES-related issues, provide end-user support, and document resolutions.
• Assist in system validation activities, including user acceptance testing (UAT) and IQ/OQ/PQ protocols.
• Ensure MES solutions comply with FDA 21 CFR Part 11, GxP, and data integrity requirements.
• Maintain and update MES documentation, including system configurations, user guides, and training materials.
• Participate in continuous improvement initiatives to enhance the efficiency of all GxP software systems on-site.
• Monitor the site's software systems performance and work with teams to ensure uptime and availability.
• Stay updated on industry trends, best practices, and regulatory requirements related to MES and digital manufacturing.
• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Qualifications:

• Available to support operations in Hopkinton MA with rotating on-call responsibilities as required.
• BS in Computer Science, Engineering or related technical discipline.
• 0-2 years of experience in MES support, manufacturing IT system or related roles (internship or co-op experience accepted).
• Basic understanding of MES (e.g., POMS, Werum Pas-X, Emerson Syncade, etc.).
• Experience with SQL, scripting languages, or system integration tools.
• Strong analytical thinking and problem-solving skills.
• Excellent time management and organizational skills.
• Excellent written and verbal communication skills.
• Strong sense of commitment and personal accountability.
• Demonstrated understanding of GxP software system project management processes, strategies, and methods.
• Experience working in a high-level collaborative environment and cross functional teams.
• Experience working in a regulated environment, 21 CFR Part 11, GAMP, etc. strongly preferred.
• Eagerness to learn and adapt in a rapidly evolving CDMO landscape.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

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