CSV / CQV Specialist

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

CSV / CQV Specialist – Computer System Validation & Equipment Qualification

About the Role

Ameri-Partners is seeking a CSV/CQV Specialist to support qualification and validation activities within a cGMP environment. This role focuses on analytical laboratory instruments, computerized systems, and GMP equipment, with responsibility for delivering inspection-ready validation documentation and supporting validation backlog remediation.

Responsibilities

• Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for analytical instruments, computerized systems, and GMP equipment.
• Prepare and maintain User Requirements Specifications (URS), risk assessments, validation protocols, test scripts, traceability matrices, and summary reports.
• Support Computer System Validation (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.

Qualifications

• 3+ years of CSV/CQV experience within pharmaceutical, biotechnology, or other regulated industries.
• Hands-on experience qualifying analytical laboratory instruments and GMP equipment.
• Strong understanding of GMP, computerized system validation, and equipment qualification.
• Experience authoring and executing validation documentation, including protocols, test scripts, and reports.
• Kneat experience strongly preferred.
• Strong technical writing, cross-functional communication, and organizational skills.
• Ability to manage multiple validation priorities in a fast-paced environment.
• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related discipline preferred.

Required Skills

• CSV/CQV experience within pharmaceutical, biotechnology, or other regulated industries.
• Qualifying analytical laboratory instruments and GMP equipment.
• GMP, computerized system validation, and equipment qualification.
• Authoring and executing validation documentation, including protocols, test scripts, and reports.
• Technical writing, cross-functional communication, and organizational skills.
• Ability to manage multiple validation priorities in a fast-paced environment.

Preferred Skills

• Kneat experience strongly preferred.
• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related discipline preferred.