IT Systems and Validation Analyst

Reporting to the Associate Director, IT Systems & Validation, the IT Systems and Validation Analyst will lead compliance-driven system validations, support IT operations for the siteand serve as a strategic liaison between business owners and the broader IT organization. This position plays a key role in ensuring system reliability, regulatory adherence, and seamless integration of technology into manufacturing and laboratory processes.

This position is based in the Northbridge, MA location, and offers a hybrid schedule.

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities

GxP Systems & Applications

• Provide support for various regulated systems including laboratory systems, manufacturing equipment, PCs, servers, and associated applications, ensuring optimal functionality and compliance.
• Lead or assist in validation efforts for GxP systems, ensuring compliance with regulatory standards and internal quality procedures.
• Author and maintain comprehensive validation documentation, including validation plans, user and functional requirements, risk assessments, test scripts, and summary reports.
• Lead system assessments (21 CFR Part 11, risk assessments), periodic reviews, and maintain required documentation.
• Drive cross-functional system implementations and large-scale validation efforts in collaboration with business partners.
• Coordinate with vendors for maintenance, upgrades, and issue resolution to minimize downtime.

IT Infrastructure & Network

• Demonstrate proficiency in troubleshooting and supporting Windows operating systems, networks, and cloud platforms such as Azure.
• Support SQL databases and provide support for applications and services that rely on these databases.
• Provide on-site IT support for the Northbridge facility, including peripherals, laptops, and A/V equipment.
• Ensure system reliability and provide proactive maintenance of critical IT infrastructure to support laboratory operations.
• Conduct regular system maintenance activities, implement necessary changes, and ensure the overall health and availability of IT systems.
• Manage user access controls and permissions to ensure the security and integrity of IT systems and applications.
• Respond to technical inquiries and provide solutions in a timely manner to minimize disruptions to laboratory operations.
• Coordinate with vendors on application and firmware updates, ensuring that system enhancements are implemented seamlessly.
• Notify system owners or business process owners of any planned upgrades, including operating system patches and hot fixes.
• Maintain comprehensive documentation of application support and ensure that changes to systems and applications are tracked and updated in accordance with regulatory/internal requirements.

Primary skills and knowledge required include, but are not limited to the following:

• Strong knowledge of GxP regulations, including 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA++).
• Experience with computerized system validation (CSV) lifecycle, including requirements development, risk assessment, testing, and documentation.
• Proficiency in supporting and troubleshooting Windows-based systems, servers, and enterprise IT infrastructure.
• Working knowledge of networking fundamentals, system administration, and cloud platforms (e.g., Azure).
• Experience with SQL databases and applications that rely on database backends.
• Familiarity with regulated laboratory and/or manufacturing systems
• Understanding of access control, security principles, and audit trail requirements in regulated environments.
• Ability to manage system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.
• Strong documentation skills with experience authoring and maintaining validation and technical support documentation.
• Effective communication and collaboration skills, with the ability to interface between technical teams, vendors, and business stakeholders.
• Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues in a timely manner.

Level of Education Required:

Bachelor’s degree or 8+ years experience in lieu of a degree

Number of Years of…