Iovance BiotherapeuticsHiring

Computer Systems Validation Analyst II

  • Remote, worldwide
  • Mid-level
  • Posted 13 days ago
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In one line

Validation analyst role covering the full computer systems validation lifecycle for lab, manufacturing and enterprise systems at a biotech firm.

About the role

Regulated systems need documentation and testing that hold up to inspectors, from user requirements through qualification. The analyst keeps projects on time and on budget while handling change controls and periodic reviews.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, worldwide
Seniority
Mid-level
Skills
21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, Agile, Waterfall
Posted
16 Oct 2026
Last checked
29 Oct 2026

What you will do

  • Write CSV lifecycle documents: plans, risk assessments, requirements, specifications and traceability matrices
  • Run testing, qualification protocols and validation reviews for lab, manufacturing and enterprise applications
  • Handle change control action items and periodic reviews of systems and data quality
  • Give frequent status updates to management, end users and clients

What they look for

  • 5 or more years of relevant industry experience
  • Degree in information technology, life science or a technical field
  • Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and ALCOA+ data integrity
  • Project management ability with strong written and spoken communication

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Questions about this job

Is this job fully remote, and from where?

Yes, it is listed as remote, and the posting does not tie it to one country.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a mid-level role. The posting asks for: 5 or more years of relevant industry experience; degree in information technology, life science or a technical field; knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and ALCOA+ data integrity. Skills it names include 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+.

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