Digital Quality Systems & Technology Engineer

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform - Encapsulated Cell Technology (ECT) platform is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel) For over two decades, we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform, designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, leveraging ECT's innovative approach to provide sustained, targeted treatment directly to the eye.

The Quality Digital Systems & Technology Engineer will collaborate and oversee the IT aspects of our Quality department. This collaborative role is pivotal in designing and simplifying processes and driving continuous improvement efforts. The ideal candidate will own this space by designing processes and effectively communicating with Quality and IT leadership. Primary responsibilities include onboarding and managing the Laboratory Information Management System (LIMS) and electronic Quality Management System (eQMS), overseeing relevant GMP computerized systems and equipment within Quality, and maintaining systems/applications. Primary responsibilities are in coordination with both Quality and IT leadership directives. The ideal candidate will have extensive experience in LIMS, eQMS, eDMS, and a proven understanding of workflow design, modification, and application administration.

Job Requirements

• Serve as the primary owner of Quality computerized systems and front-end application support.
• Act as liaison between Quality, IT, and cross-functional leadership.
• Lead LIMS and eQMS implementations, validations, integrations, and user support.
• Maintain, manage, and support Quality systems and electronic applications.
• Train Quality staff on LIMS, eQMS and other electronic systems for optimal usage.
• Identify opportunities to simplify processes and enhance system efficiencies.
• Champion continuous improvement initiatives and innovation.
• Adapt to evolving procedures and priorities with a solutions-focused mindset.
• Maintain system compliance with applicable regulatory standards.
• Own quality records related to systems (Deviations, Change Controls, CAPAs, Action Items, etc.).
• Troubleshoot system issues in coordination with IT and communicate updates effectively.
• Develop, schedule, and automate Quality testing activities aligned with commercial production.
• Ensure timely execution and coordination of Quality processes.

Education & Experience

• Bachelor’s degree in Chemistry, Life Sciences, IT, Computer Science, Engineering, or related field.
• 7-10 years of experience in Quality data management and/or IT systems.
• Demonstrated experience with LIMS, Quality Management Systems and Quality computerized systems.
• Prior work in a manufacturing or lab-based Quality environment preferred.

Knowledge, Skills & Abilities

• Strong knowledge of Quality equipment, systems, and instrumentation.
• Proficiency in laboratory software and hardware.
• Deep knowledge of IT systems and applications related to Quality Control.
• Familiarity with regulatory standards (e.g., FDA, ISO).
• Understanding of data governance and security principles (e.g., PoLP, 21 CFR Part 11 & 211, GAMP 5).
• Effective communicator with excellent interpersonal and organizational skills.
• Skilled at troubleshooting and resolving technical issues.
• Proven track record of process improvement and change management.
• Collaborative team player with a proactive, flexible approach.
• Ownership mindset with the ability to lead and drive initiatives.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.