IT Compliance and Validation Specialist – GxP, CSV Projects
Exco GmbH
full-time
Posted on:
Location Type: Hybrid
Location: Frankenthal • Germany
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Tech Stack
About the role
- Strategic planning and independent leadership of IT compliance and CSV projects in regulated industries.
- Development, implementation and optimization of tool-supported validation processes.
- Execution of 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 continuous improvement of validation processes.
- Use of and participation in the introduction of innovative technologies, e.g., AI-assisted validation or modern ALM tools.
Requirements
- Minimum 3–5 years of professional experience in the GxP environment 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 in coordinating and strategically directing validation projects.
- Knowledge of agile methods (Scrum) and experience with tools such as JIRA and Confluence.
- Structured, analytical working style and a strong commitment to quality.
- Excellent communication skills in German (C1 level) and English.
- Experience with ALM tools or AI-assisted validations is an advantage.
Benefits
- Permanent employment with security: Established company since 1994.
- Flexible working hours: You can arrange your work hours freely within flextime.
- Location-independent work: We offer a modern, well-equipped workplace and additionally give you the option to work remotely.
- Entry with onboarding program: You will be supported by a mentor so you can settle in and find your way quickly.
- Family-friendly company: We support you and your family, e.g., with childcare subsidies and 5 days of paid child sick leave with 100% salary compensation.
- Attractive compensation models: You receive an annual salary, additional vacation days and paid special leave for specific occasions.
- Overtime is compensated by time off in lieu or, if paid, with a 25% premium.
- Individual coaching: Stagnation is regression. Therefore we offer you opportunities for further development and organize training tailored to you.
- Company events: We regularly host leisure events for you and your colleagues where fun and togetherness are the focus.
- Bike leasing offers: We offer the opportunity to lease bicycles on attractive terms. The bikes are available for private and business use.
- Employee benefits and company social benefits: You enjoy many corporate benefits, e.g., a company pension plan with employer contribution, an accident insurance that also covers private use, rotating course offers in cooperation with Techniker Krankenkasse, discounts with the Pfitzer fitness group, and a company headquarters with employee parking. Our headquarters are conveniently located and easily accessible by car or public transport.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
IT complianceCSV projectsvalidation processesgap analysisrisk analysisGxP guidelinescloud IT systemson-premise IT systemsagile methodsproject management
Soft Skills
independent leadershipstrategic planningadvising clientscontinuous improvementstructured working styleanalytical working stylecommitment to qualityexcellent communication skills