Senior Computer System Validation Lead
Job Location:
Concord, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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. ** :** - 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.
Required Experience:
Senior IC
