IT System and Validation Analyst
Job in
Northbridge, Worcester County, Massachusetts, 01534, USA
Listed on 2026-09-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-09
Job specializations:
-
IT/Tech
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
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).
- 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.
- 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.
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