Quality Control & Validation Specialist

Quality Control Qualification and Validation Specialist

Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 300 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.

Main Responsibilities

• Coordination of computerized system qualification and validation activities within the Quality Control department
   
• Define the validation strategy
   
• Perform and/or support the writing of specification documents (URS)
   
• Review test protocols, plans and reports
   
• Support test execution
   
• Support and train team members in CSV methodology
   
• Supporting the timely and effective completion of investigations, change controls and CAPA?s
   

Who we are looking for

• Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
   
• Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
   
• Good understanding of analytical technologies,
   
• Strong analytical thinking and problem-solving ability
   
• Excellent communication and teamwork skills
   
• Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
   
• Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
   
• Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
   
• Good verbal and written skills in English, German is a plus