CSV Engineer - Darmstadt, Deutschland - SciPro

Beschreibung

As a CSV Engineer (m/f/x) for this exciting chemical and pharmaceutical company, you will be responsible for the support and optimization of processes within the CSV area. You'll have the opportunity to contribute your own ideas and experiences.

These tasks are waiting for you:

• Conducting computer system validations (planning, implementation, testing, and documentation of validation)
• Creating risk assessments, user requirement specifications, IQ/OQ/PQ test scripts, and validation reports
• Performing tests and documenting validation activities according to internal guidelines and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP), including the creation of test protocols
• Cooperating with internal and external partners, such as IT and quality management, to ensure efficient implementation of validation activities
• Assisting in the equipment qualification of computerized systems
• Conducting training on the validation and compliance of IT systems

This completes your profile:

• Successfully completed studies in computer science, natural sciences, or similar fields
• Thorough understanding of regulatory requirements in healthcare, including FDA guidelines, GxP standards, and other relevant regulations
• Professional experience in the field of CSV in regulated life science environments, preferably with knowledge of LIMS
• Team-oriented and structured work approach, as well as analytical thinking
• Very good German and English language skills both written and spoken

What the company offers you:

• Flat hierarchies with room for your own ideas
• Full-time position with 37.5 hours/week – Friday is a half working day
• Hybrid working environment possible
• Company pension plan
• Meal allowance
• On-site parking
• Corporate benefits

About our client:

Our client is a leading company in the development and manufacturing of chemical products and pharmaceuticals. The company is known for its quality, innovation, and customer satisfaction, serving customers in various industries worldwide.