IT Compliance and Validation Expert – GxP & CSV Projects

Exco GmbH

IT Compliance and Validation Expert leading GxP & CSV projects in the regulated sectors. Collaborating with clients to optimize validation processes and implement innovative technologies.

Posted 5/26/2026full-timeFrankenthal • 🇩🇪 GermanyMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

IT complianceCSV projectsGAP analysisrisk analysisvalidation processescloud IT systems validationon-premise IT systems validationagile methodologiesSCRUMAI-assisted validation

Soft Skills

strategic planningindependent managementclient advisingcontinuous improvementanalytical working stylecommitment to qualitycommunication skills

Certifications

GxP complianceFDA 21 CFR Part 11EU GMP Annex 11EU GMP Annex 15GAMP5