Teamlead Communication
il y a 2 semaines
Are you passionate about shaping the future of biotech through powerful storytelling and scientific communication? Do you thrive at the intersection of science, strategy, and commercial growth?
Cellistic is growing fast, and we are looking for driven team members who believe in the transformative power of engineered cells as medicines, who challenge the status quo, and who thrive on turning bold ideas into impactful results.
As a Systems Validation Lead , you will play a key role in ensuring that Cellistic’s critical IT systems and GxP-regulated equipment are robust, compliant, and future-ready. You will partner with IT, QA, and end-users to anticipate validation needs, design and execute qualification protocols, and safeguard data integrity across the system lifecycle.
The Systems Validation Lead is responsible for the qualification and validation of GxP-relevant IT systems and equipment at Cellistic, ensuring compliance with data integrity and regulatory requirements. This role supports users, IT, and QA in system lifecycle management, from procurement to retirement, and acts as the central point of expertise for Computerised System Validation (CSV). The Systems Validation Lead ensures robust documentation, oversees validation projects, and contributes to continuous improvement of validation practices to secure reliable, compliant, and efficient systems.
Participate in procurement processes to anticipate IT integration and qualification needs.
Coordinate and participate in equipment installation, commissioning, and training.
Perform Data Integrity assessments during qualification and follow up on resulting actions.
Conduct recurrent Audit Trail Reviews and ensure compliance with data integrity standards.
Operational Reliability & Risk Management
Ensure validation activities are aligned with system lifecycle management.
Data & Documentation Management
Maintain validation documentation in compliance with GMP and internal quality standards.
Support training of users on system qualification and data integrity requirements.
Master’s or Bachelor’s degree in Engineering, Life Sciences, IT, or a related technical field.
Strong knowledge of GAMP 5, data integrity principles, and applicable regulatory guidelines (Annex 11, 21 CFR Part 11).
Working knowledge of IT system lifecycle management and digital tools for validation documentation.
Organised and capable of managing multiple projects simultaneously.
Fluent in English; knowledge of French or Dutch is an advantage.
Application Process