Expert Computerized Systems Validation / CSV (m/f/d)

About the job

The Chemgineering Group is a globally operating consulting and engineering company with offices in Switzerland, Germany, Austria, Spain, Mexico, Poland, and Serbia. As specialists in efficient processes, we design and implement demanding projects for various industries in the fields of pharmaceuticals, biotechnology, fine chemicals, medical technology, cosmetics, vitamins, diagnostics, and food.

Your Tasks

• Consulting and support of our customers in the field of Computerized Systems Validation (CSV)
• Function as an interface between all departments, IT, and quality assurance
• Creation and maintenance of validation documentation for computerized systems
• Support with changes to systems considering GMP requirements
• Creation of user requirements and risk analyses
• Execution and accompaniment of tests (DQ/IQ/OQ/PQ) as well as system acceptance
• Ensuring compliance with regulatory requirements (e.g., GxP, Annex 11, Data Integrity)
• Support during audits and inspections by authorities and customers
• Participation in the further development of existing processes and documentation

Your Profile

• Completed studies or training in computer science, engineering, life sciences, or comparable
• Several years of experience in CSV in a GMP-regulated environment
• Knowledge of relevant guidelines (e.g., GxP, FDA 21 CFR Part 11)
• Experience with computerized systems (e.g., ERP, LIMS, MES) desirable
• Structured and careful working style as well as analytical thinking skills
• Strong communication skills and confident appearance when dealing with various stakeholders
• Very good German and good English skills in spoken and written form

We generally do not accept applications from recruitment agencies for this position. Thank you for your understanding.

Your Benefits at Chemgineering

Apply Now!

With our international teams, we carry out demanding consulting and planning projects and develop innovative solutions for renowned customers from the life sciences. Whether for novel cancer therapies or in the complex regulations of the chemical-pharmaceutical and biotechnological industry - in this environment, we offer you many career opportunities and excellent conditions for long-term development.
 
A family-friendly company with short communication paths, plenty of creative freedom, and a familiar corporate culture awaits you!
 
Apply now!

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