IT Compliance and Validation Expert – GxP & CSV Projects

Role Overview

• Strategic planning and independent management 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 guidelines (FDA, EU GMP, GAMP5).
• Validation of cloud or on-premise IT systems in agile or traditional projects.
• Advising clients on regulatory requirements and on continuous improvement of validation processes.
• Using and contributing to the introduction of innovative technologies, e.g., AI-assisted validation or modern ALM tools.

Requirements

• Minimum 3–5 years of professional experience in a GxP environment and knowledge of regulatory requirements (EU/US, FDA 21 CFR Part 11, EU GMP Annex 11/15, GAMP5).
• Experience working independently on projects as well as coordinating and providing strategic direction for validation projects.
• Knowledge of agile methodologies (SCRUM) and experience with tools such as JIRA and Confluence.
• Structured, analytical working style and a strong commitment to quality.
• Very good communication skills in German (C1 level) and English.
• Experience with ALM tools or AI-assisted validations is an advantage.

Tech Stack

• Cloud

Benefits

• Permanent employment: stability — our company has been established since 1994.
• Flexible working hours: you can organize your working time within our flextime arrangement.
• Location-independent work: we provide a modern, well-equipped workplace and additionally offer the option to work remotely.
• Structured onboarding program: you will be accompanied 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 child sickness leave with 100% pay.
• Attractive compensation packages: you receive an annual salary, enjoy additional vacation days and paid special leave for certain occasions.
• Overtime is compensated by time off in lieu or, alternatively, paid with a 25% supplement.
• Individual coaching: we offer opportunities for professional development and organize tailored training for you.
• Company events: we regularly host leisure events for employees and colleagues where fun and team spirit come first.
• Bike leasing options: you can lease bicycles on favorable terms for private and business use.
• Employee benefits and company social benefits: you enjoy many corporate benefits, e.g., a company pension scheme with employer contributions, private-valid accident insurance, rotating course offers in cooperation with Techniker Krankenkasse, discounts with the Pfitzer fitness group and a company headquarters with employee parking.
• Our company headquarters is conveniently located and easily accessible by car or public transport.