Senior Computer System Validation Lead
Job ID: 502279 Posted 1 day ago
Concord, North Carolina
Contract
Development and Architecture
Job Details
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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
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Why Us?
IDR has been in business for over 25 years and offers access to hundreds of companies across the country to work for. For many of the contractors that work for us, there are some unique benefits to being a part of the IDR team. One specific benefit is that we believe our contractors are part of something bigger than yourself. We are an employee-owned company and in an ESOP (Employee Stock Ownership Plan), as the share price of our company grows, so does your equity in our company. Our contractors, as well as our internal employees, can participate in this plan after one year of service. In addition to joining our ESOP program, you will also receive weekly pay, 401k access, and access to three different benefit plans that cover 50% of the individual premiums along with access to unlimited behavioral health sessions with a licensed counselor.
About Us
IDR, Inc. is an award-winning, employee-owned staffing firm with headquarters in Alpharetta, GA and offices in the Nashville, Dallas, and Denver markets. Founded in 1998, IDR has grown to serve businesses and professionals across industries including IT, healthcare, accounting and finance, government services, and professional services. Recognized for our expertise and the high-touch approach of our Engagement Management Program, IDR continues to build rewarding partnerships with companies and consultants. Our best-in-class service has earned IDR ClearlyRated’s Best of Staffing Client and Talent awards for ten consecutive years, in addition to awards from Staffing Industry Analysts and Best and Brightest Companies to Work For. With our commitment to empowering talent and developing leaders, we’re passionate about what we do and how we do it, and we look forward to working with you.