Senior Product Specialist

As a Senior Product Specialist, your primary responsibility will be to ensure that regulated systems remain compliant, validated, and fit for purpose throughout their lifecycle, while also driving effective user adoption through structured communication, training, and change management. You will act as a subject matter expert at the intersection of CSV/GxP, product ownership, and stakeholder collaboration, working closely with engineering, business, quality, and sales stakeholders.

You will support the global validation, adoption, and continuous improvement of GxP‑relevant digital products, with a particular focus on LIMS and connected laboratory systems. As Bayer continues to scale and modernize regulated platforms across regions, we are strengthening our product organization with a senior expert who can balance compliance, system validation, and user adoption.

This role is ideal for someone who is deeply grounded in validation and data integrity requirements, and who also enjoys influencing product direction and improving user experience in complex, regulated environments.

Key responsibilities

Primary focus – GxP validation & compliance

• 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), with particular focus 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).

Secondary focus – product adoption & stakeholder engagement

• 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.

Required qualifications

• 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

What we offer

• Flexible, hybrid work model

• Modern office in Warsaw

• Career development, 360° feedback, and mentoring programs

• Access to professional trainings, tools, and conferences

• Company bonus and reward structure

• VIP medical care (including dental & mental health support)

• Holiday allowance (“Wczasy pod gruszą”)

• Life & travel insurance, pension plan

• Co‑financed FitProfit sport card

• Meals subsidy, additional days off

• Home office setup & maintenance budget

• Game room and wellbeing facilities

• Relocation support to Warsaw, when applicable

Please send your CV in English.