Job Details

CQV / CSV Specialist

We are seeking an experienced and technically strong CQV / CSV Specialist with a primary focus on Automation and Manufacturing Systems to support FDA-regulated manufacturing operations at a client site in Greenville, North Carolina. This is a 4 month contract position with strong possibility to extend.

Position Overview

This role is CSV and automation-focused, working directly with the client's automation and manufacturing systems teams. The individual will be responsible for assessing, validating, and qualifying changes to previously qualified automated manufacturing lines and systems within an FDA-regulated environment. Manufacturing lines include:

• Liquid and lyophilized vial lines with RABS technologies
• Fully isolated syringe and vial combination lines
• Highly automated and robotic manufacturing systems

In addition to automation and manufacturing systems, the role may also provide CQV support for laboratory systems when needed.

Key Responsibilities

• Lead and execute Computer System Validation (CSV) and automation-related qualification activities for manufacturing systems.
• Assess, document, and qualify changes to previously qualified manufacturing lines, equipment, and automated systems.
• Support and validate PLC changes, SCADA changes, and automation system modifications.
• Perform automation validation, including understanding and assessing PLC logic and programming.
• Collaborate closely with automation, engineering, and manufacturing teams.
• Support qualification and validation of:
  • Automated manufacturing process equipment
  • Cleanroom Building Management Systems (Client)
  • Clean utilities and related control systems
  • Select IT-related systems, as applicable
• Author, execute, and review validation documentation (IQ, OQ, PQ, CSV deliverables) in compliance with cGMP, FDA, EMA, and site requirements.
• Perform risk assessments, discrepancy resolution, deviation investigations, and support change control and CAPA activities.
• Provide clear project status updates and support timely release of systems for manufacturing use.
• Support laboratory systems CQV activities as needed.

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, or a related technical discipline.
• Minimum 5 years of experience in CSV, automation validation, and CQV within pharmaceutical, biotech, or other FDA-regulated environments.
• Hands-on experience with:
  • PLC-controlled systems
  • SCADA systems
  • Automation change management and validation
• Strong understanding of:
  • Automated manufacturing process equipment
  • CSV principles and lifecycle documentation
  • cGMP, 21 CFR Part 11, EU Annex 11, data integrity requirements
• Experience supporting complex manufacturing systems, including robotic or highly automated lines.
• Experience with aseptic manufacturing operations (filling, lyophilization, isolators, RABS).
• Strong technical writing, organizational, and communication skills.
• Ability to work independently in a fast-paced, on-site manufacturing environment.