Validation Engineer - Cleaning CQV for Biopharma API

Agilent; Maryland; On-site; USD 90,000 - 120,000; Full time

Job summary

Agilent's Advanced Therapeutics Division in Colorado seeks a CQV specialist to support commissioning, qualification and validation activities in a fast‑paced API‑Biopharma setting. You will contribute to cleaning validation, method verification, and related documentation to ensure cGMP compliance.

Responsibilities include generating and reviewing validation plans, executing studies across equipment and facilities, and assisting with audits and regulatory readiness.

Qualifications

• Experience in CQV activities and related validation work.
• Strong knowledge of cGMP, FDA/ICH guidance.
• Excellent documentation, planning and organizational skills.

Responsibilities

• Generate and review validation plans, protocols and reports.
• Execute cleaning validation studies and verification activities.
• Coordinate with ENG, FAC, QA/QC and IT for validation deliverables.
• Maintain compliance with 21 CFR, ICH, and regulatory standards.
• Support audits, CAPA tracking, change controls and trend analysis.
• Prepare risk assessments, traceability matrices and summary reports.
• Assist with URS, IQ/OQ/PQ, SAT and commissioning documentation.
• Contribute to continuous improvement of the validation program.

Skills

Validation expertise

cGMP knowledge

Documentation

Education

Bachelor's degree in a relevant science

Job description

Agilent's Advanced Therapeutics Division in Colorado seeks a CQV specialist to support commissioning, qualification and validation activities in a fast‑paced API‑Biopharma setting. You will contribute to cleaning validation, method verification, and related documentation to ensure cGMP compliance.

Responsibilities include generating and reviewing validation plans, executing studies across equipment and facilities, and assisting with audits and regulatory readiness.