Computer System Validation and Quality Systems Specialist
6 days ago
This position provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data.
Key Responsibilities- Support the IT OT Systems and Development teams in tasks associated with the lifecycle of the system, including maintenance, validation, documentation, and testing.
- Update System lifecycle documentation for ITOT systems.
- Perform system periodic reviews, including data collection from the deviations database and review of impact on the system's validated state.
- Work with Site Business Integration Managers to scope resource needs for projects and site initiatives.
- Support IT OT squads in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
- Support validation activities, including generation, approval, and execution of validation protocols.
- Assist System Owners in the Periodic System Audit Trail Review.
- Act as Single Point of Contact (SPOC) for GSP111, Lifecycle Management of GxP Computerized Systems.
- Act as Single Point of Contact (SPOC) for CSV v.6, Global IT Computer System Validation.
- Work with System Owners and Business Process Owners to ensure GMP compliance for changes to systems.
- Owning and managing Veeva Quality records: Deviations, Planned Events, and CAPAs.
- Support document management systems (Veeva, Condor, eVal Roche).
- Lead or coordinate technical discussions and vendor negotiations.
- Provide leadership, technical expertise, and local implementation experience as a member of Build and Run Squads.
- Monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.
- Support regulatory audits.
We are seeking a highly skilled and experienced professional to join our team. The ideal candidate will have:
- Bachelor's degree in Computer Engineering, Automation Engineering, or similar.
- Minimum 6 years of experience in Computer System Validation and Quality Systems.
- Minimum 5 years of experience in system and/or network administration, MES Recipe Authoring, or Automation Engineering.
- Prefer experience in the life sciences Manufacturing domain.
- Prior experience in working closely with IT OT providers/vendors.
- Oversight of validation contractors, overseeing, managing, and prioritizing their work.
- System & Network Administration.
- MES Recipe Authoring and validation experience.
- Experience with industrial data and control interfaces, preferably OPC and OPC-UA.
- Ability to create and execute validation on computerized systems.
- Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.
- Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part11, cGMP Annex 11, Data Integrity principles.
- Entrepreneurial mindset, e.g. 'automating automation'.
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