Sign upLog in

CSV Lead

Karwell Technologies

Greensboro, NC

Apply
JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Computer Science, Computer Systems, Cross-Functional, Document Management, FDA (Food and Drug Administration), FDA Requirements, GxP, Human Machine Interface (HMI), Information Technology & Information Systems, Internal Audit, Laboratory Information Management System (LIMS), Laboratory Systems, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Medical Equipment, Mentoring, Pharmacy, Process Validation, Programmable Logic Controller (PLC), Quality Assurance, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Risk Analysis, SAP ECC (fka SAP R/3 and SAP ERP), Software Administration, Software Upgrades, Standard Operating Procedures (SOP), Supervisory Control and Data Acquisition (SCADA), System Validation, Technical Leadership, Validation Documentation
LOCATION
Greensboro, NC
POSTED
4 days ago
Job Description:
We are seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

Responsibilities:

  • Lead end-to-end Computer System Validation (CSV) activities for GxP computerized systems.
  • Develop and review Validation Plans, Validation Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
  • Execute and oversee IQ, OQ, and PQ activities.
  • Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements.
  • Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
  • Perform risk assessments using GAMP 5 methodology.
  • Manage deviations, CAPAs, change controls, and periodic reviews.
  • Support software implementation, upgrades, migrations, and decommissioning projects.
  • Coordinate validation activities with IT, Quality Assurance, Engineering, Manufacturing, and Business teams.
  • Support internal audits, customer audits, and regulatory inspections.
  • Mentor junior CSV engineers and provide technical guidance.
  • Maintain validation lifecycle documentation according to company SOPs.
Requirements:
  • Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
  • 8 12+ years of Computer System Validation experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
  • Strong understanding of GxP regulations and computerized system validation.
  • Experience validating enterprise systems such as:
    • LIMS.
    • MES.
    • ERP (SAP).
    • Laboratory Systems.
    • SCADA.
    • PLC/HMI.
    • Manufacturing Execution Systems.
    • Electronic Batch Records (EBR).
    • Quality Management Systems (QMS).
    • Document Management Systems (DMS).

About the Company

K

Karwell Technologies

Resume Resources

Free Resume TemplatesFree Resume Builder