Job Description

Validation Specialist

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

When you show proactivity and ambition, we’ll harness it through a variety of opportunities and challenges in the diverse areas of our business – all with a strong and meaningful purpose. Where do you want to go? What do you want to do? How do you want to make a difference? The choice is yours, and we’ll help you get there. Be better together. Be Bayer.

Main purpose: This position is part of the site Quality organization and has a strong interface with the global Quality Systems structure, contributing to governance, harmonization, and deployment of global quality initiatives at site level.

Your mission will be to:

• Lead and ensure execution of Validation activities across the site, including Processes, Cleaning, Computerized Systems, and Analytical Methods, maintaining the validated status of systems and processes.
• Ensure compliance with the Validation Master Plan (VMP), including planning, monitoring, and execution of validation and qualification activities.
• Oversee Qualification and Calibration processes for areas, equipment, and utilities, ensuring compliance with GMP and regulatory requirements.
• Provide Quality Oversight for computerized systems from a Data Integrity perspective, ensuring alignment with Bayer standards and regulatory expectations.
• Manage and govern the lifecycle of Standard Operating Procedures (SOPs), ensuring alignment with GMP requirements and Bayer Global QMS. Administer and maintain the site documentation system, ensuring consistency, compliance, and effective document control processes.
• Define, implement, and monitor the annual GMP training plan, ensuring compliance with training requirements linked to SOPs and quality processes.
• Act as Subject Matter Expert (SME) during Health Authority inspections and audits, supporting validation, QMS, and Data Integrity topics.
• Lead and support deviation, CAPA, and change control processes related to validation, documentation, and quality systems.
• Drive continuous improvement initiatives related to Validation, Data Integrity, and QMS processes across the site.
• Collaborate with cross-functional and global teams to ensure alignment with global Quality strategies and standards.
  
  Key Stakeholders & Working Relationships Production Quality Control / Laboratory Engineering & Maintenance Supply Chain Regulatory Affairs Technology & Digital / IT Global Quality / QA Systems
  
  Unlock your potential!
• University degree in Pharmacy, Chemical Engineering, Biotechnology, or related scientific discipline.
• Experience: Minimum 10 years of experience in the pharmaceutical industry.
• Strong experience in Validation (Processes, Cleaning, Computerized Systems, and Analytical Methods), Qualifications (areas, equipment, utilities), and Calibration processes.
• Experience managing computerized quality systems (laboratory and/or manufacturing) from a Data Integrity perspective.
• Proven experience interacting with Health Authorities and supporting regulatory inspections and audits is highly valued.
• Experience in documentation management and training systems within GMP environments.
• Advanced English proficiency (written and spoken).
• Proactive and positive mindset, with open, constructive communication and strong interpersonal skills.
• Demonstrated leadership capabilities, with the ability to challenge the status quo and drive continuous improvement.
• Collaborative, innovative, and resilient profile, with a strategic quality mindset and strong results orientation.
• Excellent teamwork, stakeholder management, and adaptation.

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity or gender expression. We are committed to treating all applicants fairly and avoiding discrimination.

#LI-LATAM

Período de aplicación
9/6/2026 al 23/6/2026 Código de referencia: 872926
División: Consumer Health Ubicación: Argentina : Buenos Aires : Pilar
Área funcional: Calidad
Tipo de empleo: Permanente Tiempo de trabajo
lunes a viernes, full time presencial