Strategic planning and independent leadership of IT compliance and 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 approaches.
Advising clients on regulatory requirements and driving continuous improvement of validation processes.
Utilizing and contributing to the introduction of innovative technologies, e.g., AI-assisted validation or modern ALM tools.

Minimum 3–5 years of professional experience in GxP environments and solid knowledge of regulatory requirements (EU/US, FDA CFR Title 21 Part 11, EU GMP Annex 11/15, GAMP5).
Experience working independently on projects as well as coordinating and strategically steering 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-supported validations is an advantage.

Permanent employment with long-term stability — the company has been established since 1994.
Flexible working hours: you can arrange your working time within our flexitime system.
Location-independent work: we provide a modern, fully equipped workplace and also offer mobile/remote working options.
Onboarding program: you will be supported by a mentor to help you settle in quickly.
Family-friendly company: we support you and your family, e.g., with childcare subsidies and 5 days of paid child sick leave at 100% pay.
Attractive compensation models: you receive an annual salary, additional vacation days and paid special leave for certain occasions.
Overtime is compensated with time off or paid with a 25% premium.
Individual coaching: we offer tailored training and development opportunities to support your professional growth.
Company events: we regularly organize leisure events for colleagues that focus on fun and team building.
Bike leasing: opportunities to lease bicycles on attractive terms for private and business use.
Employee benefits and occupational social services: corporate benefits such as a company pension plan with employer contribution, private-valid accident insurance, rotating course offers in cooperation with Techniker Krankenkasse, discounts for Pfitzer Group fitness studios and a company headquarters with employee parking.
Our company headquarters are conveniently located and easily accessible by car or public transport.

IT Compliance and Validation Expert – GxP, CSV Projects

Key skills