CSV Engineer

Title: CSV Engineer

Location: Hamburg Area, Germany

Type: Contract / Freelance (6 months+)

Responsibilities:

• Collaboration with global and local quality assurance and end-users for continuous enhancement of data integrity and management concepts and best practices throughout the lifecycle.
• Working with cross-functional teams on system implementations, issue resolution, and process enhancements.
• Independently maintaining and enhancing the computer system validation and data integrity program.
• In-depth understanding of regulatory requirements and their interpretation by inspectors within the pharmaceutical or medical technology industries.
• Conducting risk analyses of validation documentation, systems, and practices, and communicating identified risks, including recommending and implementing corrective actions and improvements.
• Conducting regular system reviews with system owners.
• Developing and reviewing/updating policies, procedures, templates, and forms.
• Actively supporting inspections (e.g., by regulatory authorities).
• Researching new technologies, existing processes, and references to recognized standards and frameworks.
• Identifying potentials and implementing them in the continuous improvement process.

Requirements:

• Bachelor's degree, preferably in the field of natural sciences and/or technology
• Experience in the biotech, pharmaceutical, medical technology, or a similarly regulated industry
• Minimum of 3 years' experience in the development, testing, implementation, and validation of computer systems and their quality control
• Proven successful implementation of cGMP projects
• Experience with the risk-based approach to validating computer systems
• High attention to detail, particularly regarding data consistency in documentation
• Excellent German and English language skills to articulate complex technical matters accurately

I am expecting a high volume of applicants for this position so please get in touch as a priority if you wish to be considered.

Please send your updated CV to ccorremans@optimussearch.com.