CSV Engineer
CSV Engineer
Posted on :
09-08-2025
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1 Vacancy
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Job Description
Job Summary
We are seeking a Computer System Validation (CSV) Engineer to support the validation and lifecycle management of GxP computer systems in our manufacturing and laboratory environments. This role is critical in ensuring regulatory compliance data integrity and consistent performance of computerised systems in accordance with FDA EMA GAMP 5 and other relevant regulations and guidelines.
Key Responsibilities
- Plan develop execute and document CSV activities in accordance with internal procedures and regulatory requirements.
- Author and review validation documentation such as Validation Plans User Requirements Specifications (URS) Risk Assessments IQ/OQ/PQ Protocols and Reports.
- Ensure compliance with 21 CFR Part 11 EU Annex 11 and other relevant global regulatory guidelines.
- Collaborate with cross-functional teams including IT Quality Assurance Manufacturing and Engineering to implement validated systems.
- Support audits and inspections by regulatory authorities and internal teams.
- Perform periodic reviews change control assessments and re-validation activities.
- Participate in project teams for new system implementations and upgrades.
- Provide training and guidance on CSV processes and best practices to internal stakeholders.
Requirements
Qualifications
Required:
- Bachelor s or Master s degree in Engineering Computer Science Life Sciences or related field.
- Minimum of 3 5 years of experience in CSV within the pharmaceutical biotech or life sciences industry.
- Strong understanding of GxP regulations GAMP 5 data integrity principles and validation lifecycle.
- Experience with systems such as LIMS MES ERP SCADA or laboratory equipment with software components.
- Proficient in English; German language skills are a strong advantage.
- Job is remote with some occasional travel to Germany when needed.
Preferred:
- Experience in an international pharmaceutical environment.
- Familiarity with Agile or V-model methodologies.
- Knowledge of cybersecurity principles as they relate to validated systems.
- Ability to manage multiple validation projects in parallel.
Employment Type
Full Time
Key Skills
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