A Pharmaceutical company is searching for:
Validation Engineer (CSV)
● 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
● 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
● 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.