Strategic planning and independent leadership of IT compliance and computer system validation (CSV) projects in regulated industries.
Development, implementation and optimization of tool-supported validation processes.
Conducting gap and risk analyses and ensuring compliance with GxP regulations (FDA, EU GMP, GAMP5).
Validation of cloud or on-premise IT systems in agile or traditional project settings.
Advising clients on regulatory requirements and continuous improvement of validation processes.
Utilizing and supporting the introduction of innovative technologies, e.g., AI-assisted validation or modern ALM tools.

At least 3–5 years of professional experience in a GxP environment and knowledge of regulatory requirements (EU/US, FDA CFR Title 21 Part 11, EU GMP Annex 11/15, GAMP5).
Experience in independently managing projects as well as coordinating and strategically aligning validation projects.
Familiarity with agile methodologies (SCRUM) and experience with tools such as JIRA and Confluence.
Structured, analytical working style and a strong focus on quality.
Excellent communication skills in German (C1 level) and English.
Experience with ALM tools or AI-assisted validations is an advantage.

Permanent employment with long-term stability — the company has been established since 1994.
Flexible working hours: arrange your working time within our flexitime framework.
Location-independent work: we provide a modern, well-equipped workplace and offer the option to work remotely.
Onboarding with a mentor: you will be supported by a buddy to help you settle in quickly.
Family-friendly employer: we support you and your family, for example with childcare subsidies and 5 days of paid child sick leave at 100% pay.
Attractive compensation packages: annual salary, additional vacation days and paid special leave for certain occasions.
Overtime is compensated by time off or remunerated with a 25% bonus.
Individual coaching: opportunities for tailored professional development and continued training.
Company events: regular leisure events for employees to promote team spirit and enjoyment.
Bike leasing: attractive leasing options for bicycles, available for private and business use.
Employee perks and company social benefits: numerous corporate benefits such as a company pension scheme with employer contribution, private-valid accident insurance, changing course offers in cooperation with Techniker Krankenkasse, discounts at partner fitness studios and employee parking at the company headquarters.
Our headquarters are conveniently located and easily accessible by car or public transport.

IT Compliance and Validation Specialist, GxP & CSV Projects

Key skills