Qualifications & Validations Engineer

Responsible for the proper workflow for the regulated process of qualifications and validations for GMP-relevant systems, utilities, facilities and processes for the production like filling, sterilization and packaging of pharmaceuticals.

Your responsibilities:

• Coordination and implementation of risk analyzes;
• Participation in the creation of user requirements;
• Creation and maintenance of qualification and validation plans including implementation specifications for the qualification and validation tests on systems and processes as well as coordination with the affected areas, coordination of qualification and validation tests, reviews and evaluation of the raw data including monitoring and tracking of deviations identified;
• Review and coordination of the qualification measures commissioned by the suppliers / service providers;
• Execute qualification and validation according  to GMP regulations;
• Creation of qualification reports based on the qualification protocols and raw data;
• Collecting, monitoring, checking and arranging for the archiving of the created qualification and validation plans and reports, including the collected raw data;
• Documentation of deviations and monitoring of measures for identified deviations;
• Provide validation documentation for change control evidence;
• Execute data analysis be the usage of statistical methods as appropriate to provide conclusions and recommendations for relevant work activities;
• Support the engineering team regarding GMP compliance;
• Document root cause and corrective/preventive actions of gaps found during validation and audits (CAPA);
• Be one of the main contact person during international audits of the facility;
• Handling of measurement devices for validation;
• Participate Factory Acceptance Test (FAT).

Your qualifications:

• Successfully completed bachelor's or master degree with a focus on mechanical engineering, process engineering, or a comparable course of study;
• Knowledge of the relevant GMP regulations;
• In-depth knowledge of production processes;
• Good written and spoken English knowledge;
• German would be an advantage;
• Excellent teamwork skills and solution-oriented action;
• Independent, assertive and goal-oriented way of working;
• Quick comprehension and analytical thinking;
• Self-organized way of work;
• Will for international travels inside project activities.

What we offer:

• Unlimited period contract;
• Thirteenth salary;
• Meal tickets;
• Fidelity bonuses;
• Health subscription;
• 7 Card subscription;
• Free coffee and dynamic work environment.

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.