Senior Business Applications Associate

Planet Pharma Group; Bridgewater Township (NJ); Vor Ort; USD 110.000 - 127.000; Vollzeit

Zusammenfassung

Planet Pharma seeks an experienced CSV Lead to drive validation strategy and ensure lifecycle management for computerized systems, including AI tools, under regulatory and security requirements.

You will author validation plans, review tests, and mentor team members on CSV practices while maintaining quality and compliance across multiple projects.

Qualifikationen

• 5-10+ years’ hands on experience in a validation role with responsibility for computer systems including Veeva platforms.
• Experience validating GAMP 5 (custom-built) systems.
• Experience with AI Tools/Applications and assessing GxP relevance of AI use cases.

Aufgaben

• Provide strategic leadership on CSV strategy using a risk-based approach.
• Develop CSV strategies for systems/applications including AI tool validation.
• Oversee multiple projects and drive CSV deliverables.
• Author CSV documents (Validation Plans and Summary Reports).
• Assist/co-author requirements, IQ/OQ/PQ scripts and validation protocols.

Kenntnisse

CSV validation

Veeva systems

FDA/EU regulations

Technical writing

CSA concepts

Customer service

Multi-tasking

Ausbildung

Bachelor’s in Computer Science/Engineering/Life Sciences

Tools

Veeva Quality

Veeva QMS

Veeva RIMS

Jobbeschreibung

Summary

Engage on CSV Projects as a key team member and drive CSV deliverables. Provide guidance and support to ensure computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements

Responsibilities

• Provide strategic leadership and decision making on CSV strategy using risk-based approach.
• Develop CSV strategies for different systems/applications including validation of AI Tools/Applications.
• Provide oversight and manage multiple projects at the same time. Drive CSV deliverables in the projects.
• Author CSV Documents (Validation Plans and Summary Reports)
• Assist/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 (CSV SOP, Test Execution, Gdoc. Etc.)
• Guide project team members on CSV projects ensuring team members follow laid out CSV plans
• Provide real-time oversight and support during test execution and review executed protocols
• Route CSV documents for approval(s)
• Manage & maintain CSV documents in Veeva
• Train, coach, and mentor GxP system owners.

Skills

• 5-10+ years’ hands on experience in a validation role with responsibility for computer systems specifically Veeva systems – Veeva Quality, Veeva QMS, Veeva RIMS, and other systems.
• Experience in validation of GAMP Category 5 (custom-built/bespoke) systems.
• Experience with AI Tools/Applications and assessing GxP relevance of the AI use case.
• 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.

Pay Range

$80-92/hr *based on experience