Validation Specialist – Quality & Compliance

About the role

Bayer is seeking a Validation Specialist to join its site Quality organization. The role bridges the local site with Bayer’s global Quality Systems, ensuring that validation, qualification, and documentation processes meet the highest standards of GMP and regulatory compliance.

Key responsibilities

• Lead validation activities for processes, cleaning, computerized systems, and analytical methods, maintaining validated status.
• Execute the Validation Master Plan, planning, monitoring, and reporting validation and qualification tasks.
• Oversee qualification and calibration of equipment, utilities, and areas in line with GMP requirements.
• Provide data‑integrity oversight for computerized systems, aligning with Bayer standards.
• Manage the lifecycle of SOPs and ensure robust document control within the site documentation system.
• Define and monitor the annual GMP training plan and support health‑authority inspections as a subject‑matter expert.
• Lead deviation, CAPA, and change‑control activities related to validation and quality systems.
• Drive continuous‑improvement initiatives and collaborate with cross‑functional and global teams.

Required profile

• University degree in a relevant scientific or engineering discipline.
• Strong knowledge of GMP, validation, and data‑integrity principles.
• Experience with qualification, calibration, and SOP management in a regulated environment.
• Ability to work with global quality teams and support regulatory inspections.

Required skills

• GMP compliance
• Data Integrity
• Validation Master Plan execution
• Computerized Systems oversight
• Standard Operating Procedures (SOP) management
• CAPA and Change Control processes

What we offer

• Opportunity to work in a global, innovative pharmaceutical company.
• Access to continuous learning and career development programs.
• Collaborative environment with cross‑functional expertise.