IT Systems and Validation Analyst
EyePoint
4 hours ago
Remote friendly (Northbridge, MA)
United States
IT
Primary responsibilities include:
- Provide support for 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 in accordance with regulatory standards and internal quality procedures.
- Author and maintain validation documentation (validation plans, user/functional requirements, risk assessments, test scripts, summary reports).
- Lead system assessments (21 CFR Part 11, risk assessments), perform periodic reviews, and maintain required documentation.
- Drive cross-functional system implementations and large-scale validation efforts with business partners.
- Coordinate with vendors for maintenance, upgrades, and issue resolution to minimize downtime.
IT Infrastructure & Network:
- Troubleshoot and support Windows operating systems, networks, and cloud platforms (e.g., Azure).
- Support SQL databases and applications/services that rely on them.
- Provide on-site IT support for Northbridge (peripherals, laptops, A/V equipment).
- Ensure system reliability via proactive maintenance and regular system maintenance/changes.
- Manage user access controls and permissions.
- Respond to technical inquiries promptly to minimize lab disruptions.
- Coordinate with vendors on application and firmware updates; notify owners of planned upgrades (OS patches/hot fixes).
- Maintain documentation and track system/application changes per regulatory/internal requirements.
Primary skills/knowledge:
- Strong knowledge of GxP regulations (21 CFR Part 11, Annex 11) and data integrity (ALCOA++).
- Experience with computerized system validation (CSV) lifecycle: requirements, risk assessment, testing, documentation.
- Proficiency supporting/troubleshooting Windows-based systems, servers, and enterprise IT infrastructure.
- Networking fundamentals, system administration, and cloud (e.g., Azure).
- SQL database experience for backend-dependent applications.
- Understanding of regulated laboratory/manufacturing systems.
- Access control/security and audit trail requirements in regulated environments.
- Ability to manage change control, deviations, CAPAs, and periodic reviews.
- Strong documentation, communication, collaboration, and analytical/problem-solving skills.
Education/Experience:
- Bachelor’s degree or 8+ years experience in lieu of a degree.
- Minimum 4 years in Biotech/Pharmaceutical; 4+ years supporting regulated systems or CSV projects.
Benefits/Compensation:
- Target salary range: $128,750—$163,083 USD.
- Provide support for 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 in accordance with regulatory standards and internal quality procedures.
- Author and maintain validation documentation (validation plans, user/functional requirements, risk assessments, test scripts, summary reports).
- Lead system assessments (21 CFR Part 11, risk assessments), perform periodic reviews, and maintain required documentation.
- Drive cross-functional system implementations and large-scale validation efforts with business partners.
- Coordinate with vendors for maintenance, upgrades, and issue resolution to minimize downtime.
IT Infrastructure & Network:
- Troubleshoot and support Windows operating systems, networks, and cloud platforms (e.g., Azure).
- Support SQL databases and applications/services that rely on them.
- Provide on-site IT support for Northbridge (peripherals, laptops, A/V equipment).
- Ensure system reliability via proactive maintenance and regular system maintenance/changes.
- Manage user access controls and permissions.
- Respond to technical inquiries promptly to minimize lab disruptions.
- Coordinate with vendors on application and firmware updates; notify owners of planned upgrades (OS patches/hot fixes).
- Maintain documentation and track system/application changes per regulatory/internal requirements.
Primary skills/knowledge:
- Strong knowledge of GxP regulations (21 CFR Part 11, Annex 11) and data integrity (ALCOA++).
- Experience with computerized system validation (CSV) lifecycle: requirements, risk assessment, testing, documentation.
- Proficiency supporting/troubleshooting Windows-based systems, servers, and enterprise IT infrastructure.
- Networking fundamentals, system administration, and cloud (e.g., Azure).
- SQL database experience for backend-dependent applications.
- Understanding of regulated laboratory/manufacturing systems.
- Access control/security and audit trail requirements in regulated environments.
- Ability to manage change control, deviations, CAPAs, and periodic reviews.
- Strong documentation, communication, collaboration, and analytical/problem-solving skills.
Education/Experience:
- Bachelor’s degree or 8+ years experience in lieu of a degree.
- Minimum 4 years in Biotech/Pharmaceutical; 4+ years supporting regulated systems or CSV projects.
Benefits/Compensation:
- Target salary range: $128,750—$163,083 USD.