CSV/CQV Validation Specialist for GMP Systems

Ameri-partners; New Jersey; On-site; USD 90,000 - 150,000; Full time

Job summary

Ameri-Partners is seeking a CSV/CQV Specialist to support qualification and validation activities in a cGMP environment, focusing on analytical laboratory instruments, computerized systems, and GMP equipment.

You will deliver inspection-ready validation documentation, manage backlog remediation, and collaborate with QA, QC, Engineering, Automation, Instrumentation, and system owners to ensure compliance with 21 CFR Part 11 and EU Annex 11.

Qualifications

• 3+ years of CSV/CQV experience in regulated industries.
• Hands-on qualification of analytical instruments and GMP equipment.
• Strong technical writing and cross-functional communication.

Responsibilities

• Develop and execute IQ/OQ/PQ protocols for analytical instruments, computerized systems, and GMP equipment.
• Prepare URS, risk assessments, validation protocols, test scripts, traceability matrices, and summary reports.
• Support CSV, data integrity, and compliance with 21 CFR Part 11, EU Annex 11, and GMP requirements.
• Document and resolve qualification deviations; support investigations, CAPAs, and change controls.
• Use Kneat to manage validation documentation, execution workflows, reviews, and approvals.
• Collaborate with Quality Assurance, Quality Control, Engineering, Automation, Instrumentation, and system owners.
• Review existing validation records, address documentation gaps, and support backlog remediation and inspection readiness.

Skills

CSV/CQV experience

GMP knowledge

Analytical writing

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

Job description

Ameri-Partners is seeking a CSV/CQV Specialist to support qualification and validation activities in a cGMP environment, focusing on analytical laboratory instruments, computerized systems, and GMP equipment.

You will deliver inspection-ready validation documentation, manage backlog remediation, and collaborate with QA, QC, Engineering, Automation, Instrumentation, and system owners to ensure compliance with 21 CFR Part 11 and EU Annex 11.