CQV Engineer: Lab Equipment Validation Expert

EFOR; Zuid-Holland; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

EFOR is seeking a CQV Engineer for Lab Equipment to plan, coordinate, and execute qualification activities in a cGMP setting. You will lead IQ/OQ/PQ for HPLCs, GCs, balances, incubators, and related systems, leveraging Kneat to manage documentation and workflow.

You will ensure data integrity, participate in risk assessments, and support regulatory inspections with CQV SME input. The role emphasizes cross-functional collaboration with QA, vendors, and lab users in a GMP environment.

Qualifications

• 5+ years’ CQV/Validation experience in pharma/biotech.
• Experience with lab equipment and analytical systems.
• Knowledge of GMP, GAMP, ICH, USP and data integrity.

Responsabilités

• Lead/perform CQV activities (IQ/OQ/PQ) for laboratory equipment (HPLCs, GC, balances, incubators, centrifuges, autoclaves, environmental chambers).
• Develop, review, and execute validation protocols and documentation using Kneat.
• Manage CQV documentation lifecycle (creation, routing, storage, retrieval) in Kneat.
• Coordinate with vendors, QA, lab users and stakeholders during FAT/SAT, installation and qualification.
• Review equipment design, installation, and system suitability as part of qualification.
• Document commissioning and qualification test scripts, investigate deviations, support CAPA.
• Ensure instruments are calibrated and in lifecycle compliance.
• Maintain validation master plans, schedules, and equipment lists using Kneat.
• Participate in project design reviews and provide CQV input for new equipment.
• Serve as CQV SME during inspections and audits.
• Propose process improvements related to qualification, data integrity and compliance.
• Ensure compliance with FDA, EMA and other regulatory guidance.

Connaissances

CQV / Validation expertise

Laboratory equipment know-how

Regulatory compliance

Audit readiness

Formation

Bachelor's degree or higher in Engineering or Sciences

Outils

Kneat

Description du poste

EFOR is seeking a CQV Engineer for Lab Equipment to plan, coordinate, and execute qualification activities in a cGMP setting. You will lead IQ/OQ/PQ for HPLCs, GCs, balances, incubators, and related systems, leveraging Kneat to manage documentation and workflow.

You will ensure data integrity, participate in risk assessments, and support regulatory inspections with CQV SME input. The role emphasizes cross-functional collaboration with QA, vendors, and lab users in a GMP environment.