Computer Systems Validation Analyst II
Iovance Biotherapeutics
WorldwideFully remoteFull TimeMid LevelInformation Technology
USD 120,000–135,000 a yearPosted 7 minutes agojust nowApply link checked 7 minutes ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 7 minutes ago · apply link checked 7 minutes ago
About the role
Responsibilities
- Execute and document all Computer Systems Validation lifecycle activities
- Create plans, risk assessments, specifications, testing and traceability matrices
- Manage change controls and periodic reviews of computerized systems
- Deliver validated systems on time and within budget for internal clients
- Provide status updates to management, end users and clients
Requirements
- Degree in Information Technology, Life Science or technical discipline
- 5+ years of relevant industry experience
- Knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and ALCOA+ data integrity
- Experience with Agile, Waterfall and hybrid SDLC models for regulated systems
- Strong written and verbal communication and project management skills
About the Company
- Iovance Biotherapeutics develops and delivers tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors.
- The company operates centralized, fully owned U.S.-based cell therapy manufacturing.
What we look for
- Degree in Information Technology, Life Science or technical discipline
- 5+ years of relevant industry experience
- Knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and ALCOA+ data integrity
- Experience with Agile, Waterfall and hybrid SDLC models for regulated systems
- Strong written and verbal communication and project management skills
Project ManagementData ManagementComplianceAgileRisk AssessmentDocumentationQuality AssuranceSDLCChange Management
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Iovance Biotherapeutics
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