Business Applications Associate - Senior

We’re hiring: Business Applications Associate - Senior | Computer System Validation (GxP Systems & AI)

A leading biopharmaceutical company is seeking an experienced Business Applications Associate - Senior to drive Computer System Validation (CSV) deliverables as a key member of the team. You’ll provide guidance and support to ensure computerized systems are deployed following lifecycle management and remain in a validated state in line with SOPs, regulatory, and security requirements.

What you’ll do:

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• Provide strategic leadership and decision-making on CSV strategy using a risk-based approach
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• Develop CSV strategies for different systems and applications, including validation of AI tools and applications
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• Oversee and manage multiple projects at the same time, driving CSV deliverables
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• Author CSV documents, including Validation Plans and Summary Reports
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• Assist with or co-author requirements, URS/FRS, IQ/OQ/PQ protocols, specifications, and other validation deliverables
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• Ensure project team members complete training requirements
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• Guide project teams to follow established CSV plans
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• Provide real-time oversight and support during test execution and review executed protocols
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• Route CSV documents for approval and manage them in a document management system
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• Train, coach, and mentor GxP system owners
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What you bring:

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• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field
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• 5-10+ years of hands-on experience in a validation role responsible for computer systems, specifically Veeva systems (Veeva Quality, QMS, RIMS, and others)
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• Experience validating GAMP Category 5 (custom-built) systems
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• Experience with AI tools/applications and assessing the GxP relevance of AI use cases
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• Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMP, GCP, and Data Integrity
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• Knowledge of FDA Computer Software Assurance (CSA) concepts
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• Strong technical writing skills for authoring, reviewing, and approving validation plans, requirements, test documents, and summary reports
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• Strong customer service skills for internal and external stakeholders
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• Ability to multi-task, prioritize, and manage several projects at once
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