Senior CQV Validation Engineer - GMP Facility Lead

Virtue America; California; Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Virtue America in California seeks a Senior Validation CQV Engineer with 9+ years in pharma/biotech to lead validation activities for a facility expansion and upgrade project. You will develop and execute CQV documentation, manage IQ/OQ/PQ, and ensure all systems remain in a validated state in a GMP environment.

The role requires hands-on qualification of HVAC, water systems, HPLC, bioreactors, and analytical equipment, with strong data integrity and QMS experience.

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 9+ years of validation/CQV experience in GMP environments.
• Proven experience qualifying pharmaceutical facilities, utilities, and lab/manufacturing instrumentation.
• Hands-on experience with HVAC, pharmaceutical water systems, HPLC, bioreactors, and analytical instruments.
• Strong understanding of IQ/OQ/PQ protocols, validation documentation, and lifecycle management.
• In-depth knowledge of data integrity requirements, ALCOA+ principles, and GMP regulations.
• Experience reviewing and managing QMS records, including Change Controls, Deviations, and CAPA.
• On-site in California and able to meet project timelines.

Aufgaben

• Develop, review, and maintain validation documentation, including URS, Design Specifications, IQ, OQ, PQ protocols, and final validation reports.
• Execute IQ/OQ/PQ activities for facility infrastructure, clean utilities, and QC/manufacturing equipment.
• Qualify critical pharmaceutical utilities, including HVAC and water systems, plus laboratory/manufacturing instruments such as HPLC systems and bioreactors.
• Lead periodic reviews of validated systems by evaluating asset management records and QMS documentation (Change Controls, Deviations, CAPA).
• Assess system performance, compliance history, and overall system health to recommend requalification or continued operation.
• Manage equipment decommissioning, relocation, and requalification activities for existing assets.
• Ensure validation activities comply with GMP requirements, data integrity standards, and ALCOA+ principles.
• Collaborate with Engineering, Quality Engineering (QE), Quality Assurance (QA), and Operations teams to resolve issues and meet milestones.
• Maintain accurate, traceable, and audit-ready validation records.
• Identify compliance gaps and recommend corrective actions to maintain a state of control.

Kenntnisse

CQV expertise

GMP compliance

Data integrity (ALCOA+)

Documentation & SOP writing

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

Asset management systems

QMS software

Jobbeschreibung

Virtue America in California seeks a Senior Validation CQV Engineer with 9+ years in pharma/biotech to lead validation activities for a facility expansion and upgrade project. You will develop and execute CQV documentation, manage IQ/OQ/PQ, and ensure all systems remain in a validated state in a GMP environment.

The role requires hands-on qualification of HVAC, water systems, HPLC, bioreactors, and analytical equipment, with strong data integrity and QMS experience.