Senior Product Specialist

Bayer is scaling and modernizing regulated platforms across regions, focusing on GxP-relevant digital products, particularly LIMS and connected laboratory systems. The role supports global validation, adoption, and continuous improvement of these products in complex, regulated environments.

• Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
• Minimum 5 years of experience in product specialist, validation, or similar roles.
• Strong practical experience with GxP / CSV validation of scientific or laboratory software.
• Proven experience using ValGenesis and/or Azure DevOps (ADO) for validation activities.
• Strong understanding of software development lifecycles, Agile/DevOps delivery, and regulated environments.
• Excellent communication and stakeholder management skills.

Preferred qualifications:

• Experience working with LIMS, SDMS, or SAP in regulated laboratory environments.
• Exposure to product backlog management or product ownership concepts.
• Experience working in global, multi-regional, or multi-platform environments.
• Ability to influence without formal authority and work across complex stakeholder landscapes.

• Lead and support validation activities for GxP-relevant systems delivered under Agile or DevOps models, ensuring appropriate change control, risk assessment, and documentation.
• Plan and oversee IQ, OQ, PQ activities, periodic reviews, and system decommissioning, maintaining the validated state across the full system lifecycle.
• Ensure data integrity compliance (ALCOA+), including audit trail configuration and review, electronic records, and electronic signature controls.
• Validate interfaces between LIMS and integrated systems (e.g., analytical instruments, SDMS, ERP/SAP), focusing on data flow, security, and integrity.
• Ensure role-based access control validation and support creation and maintenance of GxP-compliant training materials and training records.
• Work hands-on with validation tools such as ValGenesis and Azure DevOps (ADO).
• Drive user adoption through structured communication, training, documentation, and launch activities.
• Act as a strategic liaison between users, business stakeholders, and development teams, ensuring alignment across the product lifecycle.
• Coordinate global end-user testing, acceptance criteria, and validation scenarios aligned with business objectives.
• Communicate complex product and compliance topics clearly to both technical and non-technical audiences.
• Identify improvement opportunities by analyzing user feedback, UX metrics, and system performance, translating insights into actionable recommendations.
• Contribute to market and internal product insights that inform future development direction.
• Mentor junior specialists and support capability building within the team.