Director CSV (m/w/d)

Real Staffing; Ingolstadt; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global pharmaceutical company in Bavaria is looking for a Director of Computer System Validation. This role involves leading the CSV department, ensuring compliance with internal and regulatory requirements, and managing validation documentation. The ideal candidate should possess a degree in a relevant field, experience in IT systems within the pharmaceutical industry, and strong skills in conflict resolution. Attractive benefits include a hybrid working model and personalized training opportunities.

Leistungen

Attractive salary package

Hybrid working model

Personalized training opportunities

Free access to swimming facilities

Health management programs

Qualifikationen

• Degree in Computer Science, Pharmaceutical Engineering, or comparable qualification.
• Experience in implementing IT systems in a regulated environment.
• Proven experience in IT validation within a GxP-regulated context.

Aufgaben

• Lead the CSV department and oversee validation of computerized systems.
• Prepare validation documentation according to compliance standards.
• Qualify software suppliers and manage reporting systems.

Kenntnisse

Experience in implementing IT systems in regulated environment

Strong knowledge of GMP requirements

Proven experience in IT validation

Strong conflict-resolution skills

Excellent English skills

German language proficiency at least B2 level

Ausbildung

Degree in Computer Science or related field

Extensive experience in CSV

Tools

MS Project

Project Web App

Jobbeschreibung

Director Computer System Validation (CSV) (m/f/d)

Pharmaceutical Company in Bavaria

My client is a globally active, research‑driven pharmaceutical company based in Bavaria, specializing in the development of innovative medicines. Due to ongoing expansion, the company is currently seeking a Director Computer System Validation (m/f/d). In this role, you will report directly to the VP CSV.

Your Responsibilities

In this position, you will lead the CSV department and oversee all activities related to the validation of computerized systems in accordance with internal procedures and regulatory expectations. Your key responsibilities include:

• Managing and executing computer system validation activities following internal and regulatory requirements.
• Preparing all necessary validation documentation based on current guidelines and compliance standards.
• Creating and reviewing SOPs, risk assessments, and other quality‑related documents.
• Overseeing system documentation, archiving, system registration, training planning, and tracking.
• Qualifying software suppliers and managing reporting systems such as deviations, OOS, change control, and CAPA.
• Supporting the planning, execution, and follow‑up of audits, inspections, and self‑inspections.
• Monitoring audit trails and ensuring compliance across all systems.
• Providing troubleshooting support and managing unexpected system‑related incidents.

Your Profile

• Degree in Computer Science, Pharmaceutical Engineering, Chemical Engineering, Mechanical Engineering, Pharmacy, or comparable qualification; alternatively, extensive experience in CSV.
• Experience in implementing and maintaining IT systems in a regulated environment (pharmaceutical industry).Strong knowledge of GMP requirements.
• Proven experience in IT validation within a GxP-regulated context.
• Strong conflict‑resolution skills and a solution‑oriented, well‑organized work style.
• Experience using MS Project and Project Web App.
• High level of independence, flexibility, and sense of responsibility.
• Excellent English skills and German language proficiency at least at B2 level.

Your Benefits

• Attractive salary package
• Full-time or part-time employment possible
• Hybrid working model: home office 1-2 days per week
• Personalized training and development opportunities
• Free access to swimming facilities
• Free use of e‑charging stations
• Free parking, health management programs, childcare subsidies, job ticket
• Positive and collaborative work environment with a forward‑thinking team
• Exciting projects that keep you at the cutting edge of pharmaceutical manufacturing while continuously developing your soft skills

Are you the missing piece?

If so, we would love to hear from you!
Apply now and take the opportunity to join a team of exceptional professionals.

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📞 069 / 264898014

SThree_Germany is acting as an Employment Agency in relation to this vacancy.