Posted 3 months ago
Software Validation Engineer
AI Summary
A Software Validation Engineer plans, coordinates, and executes validation and integration testing for pharmaceutical packaging control software, ensuring compliance with GAMP 5 and regulatory requirements.
About this role
Software Validation Engineer
Our client, a leading company specialised in the development, manufacture and marketing of advanced control systems for Pharmaceutical and Cosmetics Packaging Security, starting from the identi-fication of incorrect packaging material up to the secure ejection from the packaging process.
Our client provides customers with a worldwide network of Sales & Service Centers and agencies to ensure consistent, high-level customer support on a global scale. The client is part of the COESIA Group, a group of innovation-based industrial solutions companies with almost 6.000 employees worldwide and headquartered in Bologna, Italy.
Due to a strong growing Track & Trace business and for the support of project management at their headquarter in Germany (Alsbach near Frankfurt), they are looking for a Software Validation Engineer
- Ensuring product quality in the development of complex software products for the pharmaceutical packaging process
- Validation management according to regulatory requirements (GAMP 5)
- Creation of verification and validation plans, test specifications.
- Development of new test strategies / techniques
Responsibilities
- Planning, coordination, execution and documentation of module integration and system testing in cooperation with the hardware and software development teams as part of new product development and product changes
- Monitor the completeness of validation documentation for all development disciplines
- Specification of automated test procedures to integrate into new system architectures.
- Implementation and documentation of risk analysis
- Staff training on GMP
- Care of the associated procedures for the development department
Qualifications
- Degree in computer science, electrical engineering, automation engineering or comparable work experience
- Experience in computer system validation and knowledge of regulatory requirements in the pharmaceutical environment
- Team spirit, open communication, strict quality perception and analytical problem solving awareness
- Goal-oriented, responsible and able to work independently
- Cooperative personality with a strong communication and teamwork skills
- Very good German and English
Additional Information
Interested candidates should get in touch with Nimit at +91- 954 555 1059 or email their resumes at nchaudhry (at) catenon . com
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