Regulatory Validation Coordinator (Senior)

About the role

The Senior Regulatory Validation Coordinator will lead validation and verification activities for laboratory and computerized systems within BASF's agricultural solutions unit. You will ensure compliance with OECD GLP requirements and support the integrity of data used in research and development.

Key responsibilities

• Execute validation and verification for new and modified laboratory and computerized systems according to approved strategies and OECD GLP standards.
• Prepare, maintain, and coordinate review of lifecycle documentation and SOPs for computerized systems.
• Perform validation impact and risk assessments, recommend controls and escalate decisions beyond the defined framework.
• Coordinate deviation investigations, root‑cause analysis, CAPA follow‑up and manage calibration activities for laboratory equipment.
• Provide first‑line IT support for laboratory systems, resolve issues and liaise with system owners.
• Prepare documentation for GLP audits and regulatory inspections and drive follow‑up actions.

Required profile

• Bachelor's or master's degree in Life Sciences, Biotechnology, Chemistry, Engineering, IT or a related field.
• Professional experience in GxP validation or a regulated environment with ability to independently coordinate validation and quality activities.
• Knowledge of GAMP 5 and OECD GLP guidelines; familiarity with FDA 21 CFR Part 11 is a plus.
• Strong organizational, planning and communication skills; fluent in English.
• Service‑minded, collaborative attitude with a hands‑on approach.

Required skills

• GAMP 5
• OECD GLP guidelines
• FDA 21 CFR Part 11
• GLP validation of laboratory and computerized systems
• Data integrity management
• Laboratory equipment calibration
• IT support for laboratory systems

What we offer

• Join a collaborative, international team in a regulated environment.
• Structured on‑the‑job training and knowledge transfer from day one.
• Competitive compensation, attractive benefits and clear career development paths.
• Opportunities to deepen expertise in GLP validation, data integrity and laboratory calibration.