CQV/CSV Specialist — Automation & GMP Validation Expert

Pinnaql

Greenville (NC)

On-site

USD 60,000 - 90,000

Full time

14 days+

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Job summary

A trusted consulting firm is seeking an experienced CQV / CSV Specialist to focus on Automation and Manufacturing Systems at their client site in Greenville, North Carolina. In this role, you will lead Computer System Validation tasks and support FDA-regulated manufacturing operations. Candidates must have a Bachelor’s degree and at least 5 years' experience in CSV and automation validation. This is a 4-month contract with potential for extension.

Qualifications

  • Minimum 5 years of experience in CSV, automation validation, and CQV within FDA-regulated environments.
  • Hands-on experience with PLC-controlled systems and SCADA systems.
  • Experience supporting complex manufacturing systems, including robotic lines.

Responsibilities

  • Lead and execute Computer System Validation (CSV) and automation-related qualification activities.
  • Assess and document changes to manufacturing lines and automated systems.
  • Perform automation validation and support qualification activities for laboratory systems.

Skills

Automation validation
Computer System Validation (CSV)
Strong technical writing skills
Risk assessment
Collaboration with engineering teams

Education

Bachelor’s degree in engineering, computer science, life sciences

Tools

PLC-controlled systems
SCADA systems
Cleanroom Building Management Systems (BMS)

Job description

A trusted consulting firm is seeking an experienced CQV / CSV Specialist to focus on Automation and Manufacturing Systems at their client site in Greenville, North Carolina. In this role, you will lead Computer System Validation tasks and support FDA-regulated manufacturing operations. Candidates must have a Bachelor’s degree and at least 5 years' experience in CSV and automation validation. This is a 4-month contract with potential for extension.
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