IT System and Validation Analyst
EyePoint
August 31, 2026
Remote friendly (Northbridge, MA)
United States
IT
The IT System and Validation Analyst provides QA oversight of validation and compliance for GxP-regulated computerized systems, ensuring they are implemented, maintained, and retired per global regulatory requirements, industry standards, and internal procedures.
Primary responsibilities include:
- Align internal CSV processes with GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA Computer Software Assurance (CSA) guidance.
- Serve as a CSV subject matter expert (SME) to CMC, Manufacturing Operations, Facilities, QC, QA, and Engineering.
- Own CSV lifecycle activities for implementations, upgrades, integrations, cloud/SaaS, migrations, and decommissioning.
- Author/review/approve CSV deliverables: Validation Plans; URS/FS; risk assessments; traceability matrices; IQ/OQ/PQ protocols and test scripts; validation summary reports; data integrity/system impact/Part 11 assessments; operating/admin procedures; periodic review and retirement/archival plans.
- Maintain GAMP 5-based inventory; ensure systems stay in a state of control (change control, periodic review, requalification, deviations, CAPA).
- Coordinate with vendors/managed service providers; support audits/inspections.
- Identify/escalate data integrity risks; recommend remediation.
- Document/maintain CSV and data integrity SOPs/templates; mentor teams.
- Provide administrative ownership for released systems (e.g., user setup, supplier change notifications).
Primary skills/knowledge:
- Strong CSV experience in FDA-regulated/GxP environments.
- Access control, security, audit trails, and data integrity controls.
- Change control/deviations/CAPAs/periodic reviews.
- Strong technical writing and analytical/problem-solving skills.
Education & experience:
- Bachelor’s in Engineering/Life Sciences/Computer Science or related; master’s a plus.
- 5–7+ years direct CSV experience (pharma/biotech/medical device or similar).
Salary Range: $128,750–$163,083 USD.
Primary responsibilities include:
- Align internal CSV processes with GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA Computer Software Assurance (CSA) guidance.
- Serve as a CSV subject matter expert (SME) to CMC, Manufacturing Operations, Facilities, QC, QA, and Engineering.
- Own CSV lifecycle activities for implementations, upgrades, integrations, cloud/SaaS, migrations, and decommissioning.
- Author/review/approve CSV deliverables: Validation Plans; URS/FS; risk assessments; traceability matrices; IQ/OQ/PQ protocols and test scripts; validation summary reports; data integrity/system impact/Part 11 assessments; operating/admin procedures; periodic review and retirement/archival plans.
- Maintain GAMP 5-based inventory; ensure systems stay in a state of control (change control, periodic review, requalification, deviations, CAPA).
- Coordinate with vendors/managed service providers; support audits/inspections.
- Identify/escalate data integrity risks; recommend remediation.
- Document/maintain CSV and data integrity SOPs/templates; mentor teams.
- Provide administrative ownership for released systems (e.g., user setup, supplier change notifications).
Primary skills/knowledge:
- Strong CSV experience in FDA-regulated/GxP environments.
- Access control, security, audit trails, and data integrity controls.
- Change control/deviations/CAPAs/periodic reviews.
- Strong technical writing and analytical/problem-solving skills.
Education & experience:
- Bachelor’s in Engineering/Life Sciences/Computer Science or related; master’s a plus.
- 5–7+ years direct CSV experience (pharma/biotech/medical device or similar).
Salary Range: $128,750–$163,083 USD.