Biologist (m/w/d)

Оccupation: Engineer - Biotechnology

Senior Quality Assurance Manager (m/d) Process Validation

THE COMPANY Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO). Celonic has set itself the task of effectively bringing its customers, primarily small to large biotech companies, to the marketplace, life-saving and improving drugs using innovative next-generation bioprocess technologies. Celonic has a state-of-the-art development and innovation centre in Basel, Switzerland, as well as clinical and commercial GMP production facilities in Heidelberg, Germany. More than 500 highly qualified employees currently work at Celonic. Due to the expansion of the company, Celonic is looking for dedicated and qualified employees.

THE POSITION We are looking for an experienced senior QA manager (w/m/d) process validation that supports our quality assurance department and ensures that our processes and products meet the highest quality standards. Senior QA Manager (w/m/d) Process Validation is responsible for the planning, implementation and monitoring of process validations and ensures that all relevant regulatory requirements are met. Independent planning and implementation of process validations, including the creation of validation plans and reports Monitoring of validation activities, including collection and evaluation Data Monitoring and implementation of regulatory requirements for processes and products, including GMP, FDA and EMA Communication with internal departments, including production and engineering Recording and checking of deviations, changes and quality events in the electronic deviation system (TrackWise Digital) Identification of possibilities for process optimization and implementation of improvements Implementation of employee training as part of the quality assurance activity

Master's degree in Biotechnology, Life Science or a comparable discipline At least 5 years of professional experience in quality assurance in the GMP-regulated environment, especially in process validation Good knowledge of current GMP, FDA and EMA regulations and Validation methods and procedures Embossed organisational and communication skills Very good knowledge of German and English in word and writing Self-employed and conscientious working Systematic and analytical thinking

Take influence together on the lives of patients Biotechnology is an attractive, high-growth sector with career development opportunities Celonic offers a multinational, diverse working environment We are proud to be a pioneer of “Next Generation” in manufacturing technologies Celonic is family-owned: entrepreneurial and with short communication paths Heidelberg is a great place to live, leisure and work in the heart of Europe

Joblocations:

69115 Heidelberg, Neckar, Czernyring 22, BADEN_WUERTTEMBERG, GERMANY

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