IT-Compliance and Validation Expert (m/w/d) GxP & CSV Projects

You bring more than 3 years of experience in IT validation projects with you and want to take on real responsibility? Your expertise in the GxP field is sought after – at our company, you will shape the future of Computerized System Validation (CSV) in pharmaceuticals and medical technology.

You will lead compliance and CSV projects independently, develop tool-supported validation processes, and bring your experience in validating cloud and on-premise systems into play. You will work closely with customers and use innovative technologies.

Aufgaben

• 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 as well as ensuring the adherence to GxP guidelines (FDA, EU-GMP, GAMP5).
• Validation of cloud or on-premise IT systems in agile or classical projects.
• Counseling customers on regulatory requirements and continuous improvements of validation processes.
• Using and participating in the introduction of innovative technologies, such as KI-supported validation or modern ALM tools.

Qualifikation

• At least 3-5 years of professional experience in the GxP field and knowledge of regulatory requirements (EU/US, FDA CFR Title 21 Part 11, EU GMP Annex 11/15, GAMP5).
• Experience in independent project work as well as coordination and strategic alignment of validation projects.
• Knowledge of agile methods (SCRUM) as well as experience with tools like JIRA and Confluence.
• Structured, analytical working style and high quality awareness.
• Excellent communication skills in German (C1 level) and English.
• Experience with ALM tools or KI-supported validation is an advantage.

Benefits

Unlimited employment contract with security: We have been around since 1994!

Flexible working hours: You can schedule your working hours within the framework of flexible working hours.

Location-independent work: We offer you a modern equipped workplace and give you additional opportunities for mobile work.

Onboarding program: You will be accompanied by a mentor, so that you can quickly feel at ease and find your way around.

Family-friendly company: We support you and your family, e.g. with a kindergarten allowance and 5 days of child sick leave at 100% salary compensation.

Attractive remuneration models: You will receive an annual salary, enjoy additional vacation days and paid special leave on certain occasions. Overtime work is compensated by time-off or with a 25% surcharge.

Individual coaching: Standstill is regression. Therefore, we give you the opportunity to develop further. We organize tailored training sessions for you.

Company events: We regularly host company events for you and your colleagues, where fun and the joy of being together are in the foreground.

Bike leasing offers: We offer you the opportunity to lease bicycles at attractive conditions. The bikes are available for both private and business use.

Employee benefits and corporate social benefits: You enjoy many corporate benefits, such as a company pension plan with employer contributions, an accident insurance policy that is also valid privately, changing course offers in cooperation with the Techniker Krankenkasse, discounts at the Pfitzer Gruppe fitness studio and company center with employee parking. Our company center is conveniently located and easily accessible by car or public transportation.

Why you should start at EXCO

EXCO is a family-owned technical service provider for development and quality assurance with a 30-year history of success and growth. With over 200 employees at 8 locations, we realize innovative projects for our globally operating customers from the industries of medical technology, pharmaceuticals, biotechnology, and chemistry. We offer our employees long-term career prospects and the opportunity to grow together with us in a crisis-proof industry.

You can find more information about EXCO as an employer and your entry and development opportunities on our career website.

We look forward to getting to know you!