Location: Hechingen, Germany - Fully Onsite
Position Overview
We are seeking an experienced Computer Systems Validation (CSV) Specialist / Senior Validation Lead with 7+ years of hands-on CSV experience in the biopharmaceutical industry.
The ideal candidate will be an expert in ensuring the compliance of computerized systems throughout the complete lifecycle, including software development, validation, maintenance, and decommissioning. This role requires strong technical leadership, regulatory inspection experience, and the ability to guide teams on risk-based CSV and data integrity practices.
Key Responsibilities
- Lead and execute CSV strategies and approaches for GxP computerized systems across ERP, data warehousing, laboratory, manufacturing, and other software environments.
- Provide technical leadership for CSV projects, including defining validation strategies, approaches, deliverables, and execution plans.
- Lead technical discussions regarding CSV methodology, validation content, and compliance requirements.
- Plan, execute, and document data migration activities, including testing, evidence generation, and reporting.
- Ensure strong compliance with data integrity requirements, including appropriate controls, execution, evidence, and reporting.
- Support and oversee infrastructure qualification activities.
- Provide CSV SME leadership to project implementation teams and IT teams responsible for maintaining GxP applications.
- Support FDA and EMA regulatory inspection readiness and participate in regulatory inspections as required.
- Educate, mentor, and coach IT personnel and other stakeholders with limited GxP/CSV experience.
- Support the development of effective compliance frameworks and dashboards to proactively monitor CSV and data integrity compliance.
CSV Center of Excellence (CoE)
Own and lead the CSV Center of Excellence, establishing and maintaining a robust CSV and Data Integrity framework, including:
- CSV policies and standards
- SOPs and templates
- Risk-based validation approaches
- Computer Software Assurance (CSA)
- Data integrity practices
- Compliance monitoring and continuous improvement
Community of Practice (CoP)
Lead the CSV Community of Practice to build and maintain a strong network of SMEs across the organization.
- Educate and support stakeholders ranging from CIO-level leadership to laboratory SMEs and manufacturing supervisors.
- Promote consistent application of CSV and GxP practices.
- Build organizational capability through coaching, knowledge sharing, and mentoring.
Required Qualifications
- 7+ years of hands-on Computer Systems Validation (CSV) experience
- Strong technical leadership and stakeholder management skills
- Recent biopharmaceutical industry experience
- Strong knowledge of GMP and Quality Management Systems (QMS)
- Proven experience supporting FDA and EMA regulatory inspections
- Hands-on experience with data migration planning, testing, and reporting
- Strong understanding of data integrity requirements and controls
- Experience with infrastructure qualification
- Proven ability to lead CSV strategies for individual projects
- Strong communication skills with the ability to lead technical discussions
- Experience mentoring and educating IT teams with limited GxP knowledge
- Willingness to make frequent site visits as required
Role Summary
This is a technical leadership role focused on establishing and maintaining a world-class CSV and Data Integrity framework while providing hands-on SME leadership across GxP computerized systems.
The successful candidate will be responsible for leading CSV strategy, supporting project execution, developing compliance frameworks, strengthening teams, and ensuring ongoing regulatory and quality compliance across the organization.
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