Our client, a leading healthcare solutions provider, is looking for a Business Applications - Associate-Senior-C - (Computer Systems Validation) to start right away. This position is hybrid.
Location: Bridgewater, NJ
Responsibilities- Provide strategic leadership and decision making on CSV strategy using Insmed's risk-based approach.
- Develop CSV strategies for different systems/applications including validation of AI Tools/Applications.
- Provide oversight and manage multiple projects simultaneously, ensuring successful delivery of CSV requirements.
- Author CSV Documents such as Validation Plans and Summary Reports.
- Assist and co-author requirements, UFRS/FRS, IQ, OQ, PQ protocol scripts, specifications, and other validation project deliverables.
- Ensure training requirements are complete for project team members, including CSV SOP, Test Execution, and Gdoc.
- Guide project team members on CSV projects ensuring adherence to the established CSV plans.
- Provide real-time oversight and support during test execution and review executed protocols.
- Route CSV documents for necessary approvals.
- Manage and maintain CSV documents in Veeva.
- Train, coach, and mentor GxP system owners.
Requirements- 5-10 years of hands-on experience in a validation role with responsibility for computer systems, specifically Veeva systems such as Veeva Quality, Veeva QMS, Veeva RIMS, and others.
- Experience in validation of GAMP Category 5 (custom-built/bespoke) systems.
- Experience with AI Tools/Applications and assessing the GxP relevance of the AI use case. For instance, if a business system owner introduces an AI tool to enhance product quality, evaluate its validation approach, purpose fitness, and alignment with business needs.
- Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.
- Strong technical writing skills for authoring, reviewing, and approving validation plans, requirements, testing documents, and summary reports.
- Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.
- Strong customer service skills for internal and external customers.
- Ability to multi-task on different projects and prioritize efforts effectively.
Education: Bachelor's in Computer Science, Engineering, Life Sciences, or a related field.
Contract Duration: 12 months
Pandologic. Keywords: Writer and Author, Location: Bridgewater, NJ - 08807 , PL: 604766650
