Software Validation Engineer

Catenon india; Alsbach-Hähnlein; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Catenon india is looking for a Software Validation Engineer based in Alsbach, Germany. The role involves ensuring product quality in the development of complex software products for the pharmaceutical packaging process, focusing on validation management as per regulatory standards.

The ideal candidate will have a relevant degree, experience in computer system validation, and strong communication skills in German and English. Join a dynamic team as they support the Track & Trace business and contribute to innovative packaging solutions.

Qualifikationen

• Experience in computer system validation and knowledge of regulatory requirements in the pharmaceutical environment.
• Very good German and English communication skills.
• Goal-oriented, responsible, and able to work independently.

Aufgaben

• Planning, coordination, and documentation of module integration and system testing.
• Monitor validation documentation for all development disciplines.
• Implementation and documentation of risk analysis.

Kenntnisse

Computer system validation

Regulatory requirements knowledge

Analytical problem solving

Team communication

GMP training

Ausbildung

Degree in computer science, electrical engineering, or automation engineering

Jobbeschreibung

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 identification 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.

Job Description

• 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