Job Description
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.
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.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. We design our products and services to serve the most essential human needs of health and nutrition. At the same time, we strive to address some of the world’s biggest challenges presented by a growing and aging global population. At Bayer, we’re committed to driving sustainable development and generate a positive impact with our businesses. Through the power of science, we’re pioneering new possibilities that advance life for all of us. That means reimagining how we care for ourselves and one another by empowering everyday health, improving approaches to patient care, and finding better ways to nourish our communities around the world. Data Privacy Statement & Imprint: https://www.bayer.com/en/glob-li-bayer-en-dps-imprint
Industry: Chemical Manufacturing