What are the responsibilities and job description for the Senior Computer System Validation Lead position at IDR, Inc.?
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