Systems and Equipment Validation Manager

About the role

The Manager for Systems and Equipment Validation will lead the qualification and validation lifecycle of computerized systems, laboratory equipment, utilities and related processes at Bionique Testing Laboratories. This role ensures compliance with FDA, EMA, ICH, GAMP, GMP and ISO regulations while supporting the company’s biopharmaceutical testing services.

Key responsibilities

• Lead validation strategies for CSV, LIMS, lab equipment and utilities, reviewing and approving URS, risk assessments, IQ/OQ/PQ protocols, test scripts and final reports.
• Coordinate with QA on cross‑functional projects, change control, deviation investigations and CAPAs, and provide oversight during system upgrades, decommissioning and requalification.
• Support internal and external audits, maintain validation master plans, equipment master lists and monitor KPIs for validation activities.

Required profile

• Bachelor’s degree in a scientific, engineering or related technical discipline.
• Minimum 5 years of experience in quality assurance or validation within a GMP‑regulated environment.
• Strong knowledge of validation principles (CSV, equipment, facilities, utilities) and applicable regulatory guidelines.

Required skills

• Computerized System Validation (CSV)
• Experience with LabVantage, ZenQMS, BlueMountain, Veeva or similar quality systems
• Knowledge of GAMP 5, risk‑based validation and data integrity
• Ability to author and review validation documentation (URS, IQ/OQ/PQ, protocols, reports)