IT System and Validation Analyst

Scorpion Therapeutics; Northbridge (MA); On-site; USD 129,000 - 163,000; Full time

Job summary

Scorpion Therapeutics seeks an IT System and Validation Analyst to provide QA oversight of validation and compliance for GxP-regulated computerized systems, ensuring they are implemented, maintained, and retired per global regulatory requirements.

The role partners with CSV SMEs across functions, owns lifecycle activities for deployments and decommissioning, authors validation deliverables, and maintains data integrity and change control.

Qualifications

• 5–7+ years direct CSV experience in pharma/biotech/medical devices.
• Experience with FDA 21 CFR Part 11, EU Annex 11, CSA guidance.
• Strong technical writing and analytical skills.
• Experience with validation lifecycle processes.

Responsibilities

• Align CSV processes with GAMP 5 and Part 11, CSA guidance.
• Own CSV lifecycle activities for implementations, upgrades, migrations, and decommissioning.
• Author/review/approve validation plans, IQ/OQ/PQ, and protocols.
• Maintain change control, deviations, CAPAs, and data integrity.
• Coordinate with vendors and support audits/inspections.

Skills

CSV experience

GxP compliance

Regulatory knowledge

Technical writing

Problem solving

Education

Bachelor’s in Engineering/Life Sciences/Computer Science

Master’s degree a plus

Job description

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.