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:

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

What you bring:

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