CSV Engineer - Bend, Oregon, USA

Advanced Manufacturing Tech Solutions; Bend (OR); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

AMTSOL is seeking a CSV/CQV Specialist to support qualification and validation activities within a cGMP environment, focusing on instrument and equipment qualification and backlog remediation.

You will develop and execute validation documentation (URS, risk assessments, protocols, test scripts, traceability matrices and reports), support 21 CFR Part 11/EU Annex 11 compliance, and partner with QC, QA, Engineering and Automation to drive inspection-ready documentation.

Competenze

• 3–5+ years’ CQV/CSV experience in regulated industries.
• Bachelor’s degree in engineering or life sciences or chemistry or biology preferred.
• Strong GMP / CQV / CSV background.
• Experience with analytical laboratory instrument qualification.
• Hands-on equipment qualification experience.
• Kneat experience strongly preferred; excellent technical writing.

Mansioni

• Support IQ/OQ/PQ for analytical instruments, computerized systems and GMP equipment.
• Develop and execute validation documentation, including URS, risk assessments, protocols, test scripts, traceability matrices and reports.
• Support CSV, data integrity, 21 CFR Part 11, EU Annex 11 and GMP compliance.
• Partner with QC, QA, Engineering, Automation, Instrumentation and system owners.
• Manage deviations, CAPAs, change controls and validation backlog activities.
• Use Kneat for validation documentation, workflows and approvals.
• Help drive inspection-ready documentation and backlog remediation.

Conoscenze

CQV/CSV experience

GMP knowledge

Instrument qualification

Documentation writing

Multi-priority management

Formazione

Bachelor’s degree in Engineering/Life Sciences/Chemistry/Biology

Strumenti

Kneat

Descrizione del lavoro

AMTSOL is seeking a CSV/CQV Specialist to support high-priority qualification and validation activities within a cGMP environment. The role focuses on the qualification of analytical instruments, computerized systems and GMP equipment, and on driving inspection-ready validation documentation and backlog remediation.

Key Responsibilities

• Support IQ/OQ/PQ for analytical instruments, computerized systems and GMP equipment.
• Develop and execute validation documentation, including URS, risk assessments, protocols, test scripts, traceability matrices and reports.
• Support CSV, data integrity, 21 CFR Part 11, EU Annex 11 and GMP compliance.
• Partner with QC, QA, Engineering, Automation, Instrumentation and system owners.
• Manage deviations, CAPAs, change controls and validation backlog activities.
• Use Kneat for validation documentation, workflows and approvals.
• Help drive inspection-ready documentation and backlog remediation.

Requirements

• 3–5+ years’ experience in CQV/CSV within pharmaceutical, biotech or regulated industries.
• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology or a related field preferred.
• Strong GMP / CQV / CSV background.
• Analytical laboratory instrument qualification experience.
• Hands-on equipment qualification experience.
• Kneat experience strongly preferred.Excellent technical writing and documentation skills.
• Able to manage multiple priorities in a fast-paced environment.