Product Manager – Validation Officer

What will you do?

As part of our team, you will be a key driver behind the development and success of our products and projects. You will be responsible for the full lifecycle — from development and validation to release and continuous optimization.

You will coordinate and execute the Validation Master Plan for each product or project and act as the central point of contact for all CAPA-related activities, supporting improvement initiatives and product optimization in close collaboration with internal departments.

Machines developed for pharmaceutical and medical device applications are validated according to the GAMP5 validation model. Machine data complies with ALCOA principles, including 21 CFR Part 11 requirements.

Each machine is validated both as:

• a project component (customer-specific product requirements), and
• a product component (machine and software platform),

with both elements validated individually and as an integrated system.

You will work closely with After-Sales Service, Engineering, Production, and QA teams.

We offer a competitive salary package aligned with your experience and profile.

Your Responsibilities

• Independently develop and document a risk-based validation strategy
• Prepare and execute Validation Master Plans and Product & Project Validation Plans
• Perform product and project validation, including process and software validation
• Prepare validation documentation in accordance with applicable guidelines
• Identify and implement efficiency monitoring tools
• Initiate and manage CAPA activities, defining improvements and action plans
• Align proposals with internal stakeholders
• Perform complex data analyses in Excel for root cause analysis and optimization
• Support and train departments in problem-solving methodologies
• Investigate urgent and critical product or process issues, including incident handling
• Ensure knowledge retention and cross-department knowledge sharing