IT Systems and Validation Analyst
EyePoint
9 days ago
Remote friendly (Northbridge, MA)
United States
IT
Primary responsibilities include:
- GxP Systems & Applications
- Support regulated systems (laboratory systems, manufacturing equipment, PCs/servers, and related applications) to ensure functionality and compliance.
- Lead or assist validation efforts for GxP systems in line 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 and periodic reviews (including 21 CFR Part 11 and risk assessments) 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 (peripherals, laptops, A/V) for the Northbridge facility.
- Maintain critical IT infrastructure reliability via proactive maintenance and regular system upkeep.
- Manage user access controls and permissions to protect security and data integrity.
- Respond to technical inquiries promptly to minimize disruptions.
- Coordinate vendor updates (application/firmware) and notify owners of planned OS patches/hot fixes.
- Maintain and track application support documentation/changes per regulatory/internal requirements.
Required qualifications/skills:
- Strong knowledge of GxP (21 CFR Part 11, Annex 11) and data integrity principles (ALCOA++).
- CSV lifecycle experience (requirements, risk assessment, testing, documentation).
- Proficiency supporting/troubleshooting Windows systems, servers, and enterprise IT.
- Networking fundamentals, system administration, and cloud (Azure).
- SQL/database experience.
- Understanding access control, security, and audit trail requirements in regulated environments.
- Ability to manage change control, deviations, CAPAs, and periodic reviews.
- Strong documentation and communication/collaboration skills.
Education/experience:
- Bachelor’s degree or 8+ years equivalent experience.
- Minimum 4 years in biotech/pharmaceuticals; 4+ years supporting regulated systems or CSV projects.
- GxP Systems & Applications
- Support regulated systems (laboratory systems, manufacturing equipment, PCs/servers, and related applications) to ensure functionality and compliance.
- Lead or assist validation efforts for GxP systems in line 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 and periodic reviews (including 21 CFR Part 11 and risk assessments) 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 (peripherals, laptops, A/V) for the Northbridge facility.
- Maintain critical IT infrastructure reliability via proactive maintenance and regular system upkeep.
- Manage user access controls and permissions to protect security and data integrity.
- Respond to technical inquiries promptly to minimize disruptions.
- Coordinate vendor updates (application/firmware) and notify owners of planned OS patches/hot fixes.
- Maintain and track application support documentation/changes per regulatory/internal requirements.
Required qualifications/skills:
- Strong knowledge of GxP (21 CFR Part 11, Annex 11) and data integrity principles (ALCOA++).
- CSV lifecycle experience (requirements, risk assessment, testing, documentation).
- Proficiency supporting/troubleshooting Windows systems, servers, and enterprise IT.
- Networking fundamentals, system administration, and cloud (Azure).
- SQL/database experience.
- Understanding access control, security, and audit trail requirements in regulated environments.
- Ability to manage change control, deviations, CAPAs, and periodic reviews.
- Strong documentation and communication/collaboration skills.
Education/experience:
- Bachelor’s degree or 8+ years equivalent experience.
- Minimum 4 years in biotech/pharmaceuticals; 4+ years supporting regulated systems or CSV projects.