Computer System Validation Experts in Germany
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Meet FRATCH Experts in Germany, who have recently used Computer System Validation
Florian Ripper
Last position:
Global Programme Lead, Ecosystem Separation at Merck Group
Electronics – Surface Solutions | Carve-out of IT, data and system landscape*
Separation of a full business division's IT, data and system landscape following divestment; centrally governed investment envelope in the three-digit m€ range
Laboratory notebook and laboratory analytics platform stream: Palantir Foundry, Snowflake, Signals Notebook, Power BI and connected laboratory instrumentation; site transition completed without interruption to laboratory operations
Decision authority and escalation point for business, IT infrastructure, IT security and vendors; separation executed across globally distributed users and systems, handed over on schedule
Manfred Böttcher
Last position:
Interim Manager Managing Director
- Optimization of business results and expansion of sales activities
- Responsible for personnel organization
- Introduction of a document management system (DMS)
- Introduction and optimization of the ERP, CMS and CRM landscape
- Introduction of digital signatures
- Increase in revenue, reduction in costs and increase in EBIT
Dieter Schraad
Last position:
Overall process responsibility for OTC including harmonization, target picture definition and governance / requirements and at Qiagen AG
- Transition from SAP ECC to S/4HANA in an international pharmaceutical environment
- Analyze & optimize SAP order-to-cash processes with focus on SAP SD, CS and GTS
- Ensure alignment of all process steps from order entry through delivery and billing to payment
- Define global end-to-end process standards
- Moderate goal conflicts between local units and the global model
- Prepare decision templates for management
- Evaluate process variants independent of system implementation
- Manage incidents, changes and requirements via Jira; use Confluence for central project documentation
- Support the setup of test management in Jira Xray
- Manage order processing, billing as well as subscription and milestone billing
- Improve receivables processes, integrate third-party tools and monitor metrics like cash cycle time and invoice accuracy
- Derive work packages and define milestones based on analysis
- Quality assurance in requirements management between business and IT service providers
- Prepare and moderate decision formats, management briefings and status meetings at the C-level
- Set up and maintain standardized reporting (status reports, milestone tracking, risk register)
- Ensure compliance with existing governance and reporting requirements
- Apply standards and methods in the pharmaceutical industry, including GxP and computer system validation (CSV)
Detlef Huß
Last position:
PRINCE2® Coach at BITMARCK Beratung GmbH
- PM methodology transfer for PRINCE2® / PRINCE2 Agile®
- Consolidation and design of a company-wide project management standard: "Back to PRINCE2®!"
- Transfer of a unified, universal, comprehensive, robust, stringent, easy-to-apply, and scalable methodology
Jovan Jelic
Last position:
CSV Manager, Technical Engineering at CureVac Printer GmbH
- Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 requirements are met
- Coach implementation teams in the proper execution of validation documents
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Coordinate audits of internal computer systems validation activities, protocols and procedures, and prepare responses
- Identify and qualify all computer systems impacting cGMP operations using a risk-based methodology
- Develop CFR Part 11 computer systems validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ protocols and all deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage their execution
- Act as CSV lead for all validation projects and execute or oversee validation plans and documents
- Perform project management activities for the CSV process within the scope of system projects
- Work with project manager to include validation activities in implementation timelines
- Manage internal CSV resources to facilitate completion of qualification activities
- Ensure initiation, preparation and closeout of all CSV-related deviations, discrepancies and change control documents
- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
- Conduct or facilitate validation and 21 CFR Part 11 training
Vishal Vekariya
Last position:
GMP Referent in Quality Assurance - Validation Group at Menarini Von Heyden GmbH
- Working as a CSV (Computer System Validation) Engineer in QA
- Primary focus on corporate project: implementation of the manufacturing execution system (MES)
- Assisted in the planning and coordination of multiple sub-projects, maintaining project documentation
- Adept validation life cycle according to GAMP 5 (URS-FS-DS-FAT-SAT-IQ-OQ-PQ) to ensure compliance with regulatory standards
- Reviewed and approved master batch record (MBR) validation reports
- Monitored project performance against KPIs, ensuring continuous alignment with business goals and project scopes
- Managed the validation and integration of the SAP-MES interface, demonstrating a strong command of computer system validation (CSV) principles
- Experienced with quality management systems, for instance TrackWise
- Facilitated daily cross-departmental communication and alignment with external suppliers to ensure project milestones are met on schedule
Praveen Kumar A
Last position:
Safety Regulatory Intelligence Consultant at Sanofi Aventis Deutschland GmbH
- Provide expert advice and support in the development of a software intelligence tool for monitoring worldwide legislation changes in the field of post marketing safety and regulatory activities and implementation of process workflow
- Application: Safety Regulatory Intelligence
- Activities: Requirement gathering, conceptualization of process and workflow, vendor selection, etc.
- Tools used: SharePoint, JIRA, Miro
Florin Burdea
Last position:
Hands-On Process Manager / Polarion System Admin at Metrax GmbH
Hands-on ALM-solution configuration: process refinement (BPMN), workshops and stakeholder management
Product development templates configuration and validation
Full traceability and decomposition
Tailored to fulfill 62304 internal SOP requirements and 29119
Regular meetings, metrics and dashboards
Work item workflows and link roles
User roles and rights
Prepared work instructions, training and rollout
Tools: Polarion (Siemens ALM), MS Visio, MS PowerPoint
Franz Hamberger
Last position:
Software Developer at Roche Diagnostics GmbH
- Implementing microservices in C# using dapr and Docker for a system to exchange analysis requests and results between laboratory systems
- Implementing a test automation framework with C# and SpecFlow for this system
- Build and release management with GitLab
- Evaluating laboratory systems for extensibility (using Python) and integration
Jens Meßinger
Last position:
Fullstack Developer / Team Lead at Self-employed (Meßinger & Rantzuch GbR)
- Provided fullstack web development as a new development and replacement of existing desktop and web applications for an ERP solutions provider in the education sector
- Analyzed and redesigned development processes and collaboration in distributed teams
- Responsibilities included team leadership, conceptual design, architecture, implementation, DevOps and consulting
- Technologies: C# & .NET (ASP.NET 7), Angular 14, JavaScript/TypeScript, OData/REST, SOAP, Azure DevOps
- Integrated interfaces to educational providers and authorities
Michael Renner
Last position:
Scrum Master, Project Manager and SAP BI Consultant at Self-employed / maconvis Dienstleistungen GmbH
Discover over 15,000 top freelancers
Statistics of experts using Computer System Validation
Aggregated from the professional profiles of matched freelancers.
Experience
22 years
Position duration
2.2 years
Positions per freelancer
11
Top business areas
Quality Assurance, Information Technology, Product Development
Top industries
Information Technology, Manufacturing, Pharmaceutical
Certification focus areas
Information Technology, Project Management, Quality Assurance
Bachelor's degree or higher
90%
Master's degree or higher
50%
Doctorate
10%
Certifications per freelancer
3
Most common languages
German, English, Hindi
Speak two or more languages
100%
Based on our profile pool as of 30 Aug 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Germany are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge within that range.
Average rates of experts in Germany using Computer System Validation
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 30 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
What CSV covers
Computer System Validation, often called CSV, proves that a system works as intended in a regulated setting. It is used for software that affects product quality, patient safety, data integrity, or traceability. Strong experts understand the full validation lifecycle, not just test execution.
Where it is used
- GxP software and controlled business processes
- Laboratory and quality systems such as LIMS and QMS
- Manufacturing and shop-floor systems, including MES and SCADA
- Cloud services, interfaces, and data flows that support regulated records
In Germany, CSV work often sits between QA, IT, and operations. Specialists must document decisions clearly and keep evidence consistent across teams.
Common standards
CSV work is usually shaped by GAMP 5, GxP expectations, and data integrity rules. Experts may also work with risk assessments, URS, functional specs, traceability matrices, and SOPs. The goal is controlled evidence, not paperwork for its own sake.
When companies bring in freelancers
Companies often need freelance support for new system rollouts, upgrades, migrations, remediation work, or audit preparation. They also bring in specialists when internal teams lack validation depth or need a fresh review of gaps. In Germany, this is common when local teams need both English documentation and clear coordination with site stakeholders.
What strong professionals do
A strong CSV specialist can turn business needs into testable requirements, design risk-based test cases, and keep traceability tight from start to finish. They know how to write protocols, support deviations, and defend decisions during audits. Good work is precise, practical, and easy to follow.
Signs you need CSV help
- You are launching or replacing a regulated system
- Validation documents are inconsistent or incomplete
- Audit findings point to weak evidence or missing traceability
- Your team needs help with supplier assessment or CSV strategy
Freelance experts are useful when deadlines are tight and the system scope is clear, but the evidence needs to be stronger.
Frequently asked questions
Not sure where to start with Computer System Validation? These answers cover the essentials.
Computer System Validation is used to show that a computerized system performs as intended in a regulated environment. It supports quality, safety, and data integrity for systems such as LIMS, QMS, MES, and other GxP tools. The work also creates the evidence needed for audits and internal reviews.
CSV is the broader practice, while GAMP 5 is one of the main frameworks used to guide it. In practice, many teams use GAMP 5 principles to decide the validation approach, the level of testing, and the amount of documentation. A good specialist knows when risk-based thinking is enough and when stricter control is needed.
A strong Computer System Validation specialist usually understands QA, risk assessment, data integrity, and change control. Experience with URS, traceability matrices, SOPs, and supplier documentation is also important. If a system connects to labs or production, knowledge of interfaces and controlled records helps a lot.
Computer System Validation work can be small or very deep, but most projects need someone who has handled regulated systems before. Simple document updates may only need focused support, while a system rollout or remediation effort needs broader experience across planning, testing, and audit readiness. The more critical the system, the more valuable prior hands-on practice becomes.
Computer System Validation is not just software testing. It adds regulated requirements, traceability, approved evidence, and documented justification for every important decision. A system can pass functional tests and still fail CSV if the records, risk logic, or approval trail are weak.
Yes, much of CSV can be done remotely if document access, review cycles, and stakeholder communication are well organized. For system walkthroughs, workshops, or final sign-off discussions, on-site presence can still help. In Germany, many teams use a hybrid setup so the specialist can work closely with QA and operations.
Look for clear reasoning, clean documentation, and a risk-based approach to Computer System Validation. Strong work shows traceability from requirements to tests, sensible handling of deviations, and language that auditors can follow. You should also see evidence that the specialist can adapt the approach to the system, not force the same template everywhere.
CSV focuses on computerized systems, while paper-based process validation relies on different kinds of evidence and control. The two often overlap in regulated environments, but the review logic is not identical. A skilled specialist knows how to keep the system scope clear so the validation package stays accurate.
The average hourly rate of freelancers in Germany who have used Computer System Validation in their recent projects is 119 €, which corresponds to a daily rate of about 951 € based on an 8-hour working day.
Of the freelancers in Germany who have used Computer System Validation in their recent projects, 90% hold at least a Bachelor's degree, 50% hold at least a Master's degree, and 10% hold a doctorate.
On average, freelancers in Germany who have used Computer System Validation in their recent projects have 22 years of professional experience, with a single engagement typically lasting around 2.2 years.
The most common languages among freelancers in Germany who have used Computer System Validation in their recent projects are German (100%), English (100%), and Hindi (18%).
The most common industries among freelancers in Germany who have used Computer System Validation in their recent projects are Information Technology (73%), Manufacturing (73%), and Pharmaceutical (73%).
The most common business areas among freelancers in Germany who have used Computer System Validation in their recent projects are Quality Assurance (91%), Information Technology (82%), and Product Development (73%).
Main locations of FRATCH Experts, who have recently used Computer System Validation
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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Philipp Thomaschewski
FRATCH CEO
