IDR, Inc.
IDR, Inc.

Senior Computer System Validation Lead

Concord, NC, US • Posted 22 hours ago • Updated 22 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Life Sciences
  • Pharmaceutical Industry
  • Collaboration
  • SAP EWM
  • SCADA
  • Programmable Logic Controller
  • GMP
  • Documentation
  • URS
  • DS
  • DirectShow
  • IQ
  • OQ
  • PQ
  • GxP
  • Quality Management
  • Computerized System Validation
  • Pharmaceutics
  • Medical Devices
  • MES
  • GAMP
  • Regulatory Compliance
  • Data Integrity
  • Management
  • Manufacturing
  • Life Insurance
  • Recruiting
  • Artificial Intelligence
  • Privacy
  • Quality Control
  • Quality Assurance

Summary

IDR is seeking a Senior Computer System Validation Lead to join one of our top clients 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.

Position Overview for the Senior Computer System Validation Lead:
  • 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 for the Senior Computer System Validation Lead:
  • 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.

What's in it for you?
  • Competitive compensation package
  • Full Benefits; Medical, Vision, Dental, and more!
  • Opportunity to get in with an industry leading organization.

Why IDR?
  • 25+ Years of Proven Industry Experience in 4 major markets
  • Employee Stock Ownership Program
  • Dedicated Engagement Manager who is committed to you and your success.
  • Medical, Dental, Vision, and Life Insurance
  • ClearlyRated's Best of Staffing Client and Talent Award winner 12 years in a row
#LI-Onsite

By submitting this application, you acknowledge and consent to engage in conversation with a recruiter or virtual recruiter from IDR Inc. and its affiliates, and contracted partners by receiving calls, AI-generated calls, texts, or emails to the contact information provided. Please ensure that the contact information provided is one you are permitted to use and are authorized to receive such messages on. If your contact information changes during the application process, please notify IDR promptly. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can opt-out of receiving communications at any time by saying or replying with "STOP" and "HELP" for help. To view our privacy policy, you may access it here (;br>PandoLogic. Keywords: Quality Control / Quality Assurance Manager, Location: Concord, NC - 28026
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: pandfeed
  • Position Id: 603802799
  • Posted 22 hours ago
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