We’re hiring: Business Applications Associate - Senior | Computer System Validation (GxP Systems & AI)
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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 xhqgsiq 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
Business Applications Associate - Senior in bridgewater at Unknown Company
This position is listed as full time and onsite.