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Senior Computer System Validation LeadOmegaHires • Concord, NC, United States
Senior Computer System Validation Lead

Senior Computer System Validation Lead

OmegaHires • Concord, NC, United States
1 day ago
Job type
  • Full-time
Job description

Senior Computer System Validation Lead

Job Title: Senior Computer System Validation Lead

Location: Concord, NC (Complete Onsite)

Position Overview: We are seeking a Senior Computer System Validation Lead to join our team for an onsite opportunity in Concord, NC. This role involves leading validation strategies and executing validation activities for manufacturing systems within a regulated environment, primarily in the life sciences or pharmaceutical industry. The ideal candidate will collaborate with cross-functional teams to ensure compliance with regulatory standards and support digital manufacturing initiatives.

Key Responsibilities:

  • Lead end-to-end CSV lifecycle activities for manufacturing systems, including MES and automation systems.
  • Act as CSV Lead/SME for manufacturing programs, providing guidance on validation strategy, execution, and compliance.
  • Support validation for systems such as MES, SAP EWM, Tulip, SCADA, PLC, and other GMP-regulated applications.
  • Author, review, and approve validation documentation, including Validation Plans, URS, FS/DS, IQ/OQ/PQ Protocols, and system summaries.
  • Ensure compliance with FDA, GAMP5, GxP, Data Integrity principles, and internal quality systems.

Requirements:

  • 10+ years of experience in Computer System Validation within regulated manufacturing environments (Pharma/Biotech/Medical Devices).
  • Strong hands-on experience with MES validation and automation-integrated systems.
  • Proven experience working in shop-floor environments and automation systems.
  • Expertise in GAMP5 risk-based validation, FDA 21 CFR Part 11 & Annex 11 compliance, and Data Integrity (ALCOA+).
  • Ability to lead cross-functional teams, handle regulatory inspections, and manage stakeholders across IT, Quality, and Manufacturing.
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Senior Computer System Validation Lead • Concord, NC, United States

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