(Senior) Biosafety Officer (GMP, FDA)
Opis stanowiska pracy
SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands.
The CompanyFor more than 25 years, Janssen Biologics has been a leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their work has revolutionized the science of immunology. They pioneered monoclonal antibody technology, a cutting-edge approach that launched a new generation of products to treat immune-related diseases. Janssen Biologics is a wholly owned subsidiary of Johnson & Johnson.
Role DescriptionAs biosafety professional / biosafety officer you will work for the Vaccines Launch Facility (VLF), located at the site of Janssen Biologics in Leiden. Your main task will be to lead the implementation of biosafety procedures and standards in the VLF, and to ensure corporate and legal compliance.
Responsibilities• Update the biosafety training for the VLF
• Perform periodic training for new and existing personnel (including lab staff, cleaning personnel, maintenance engineers)
• Update biosafety risk assessment
• Review and align protocols and procedures
• Created and/or adjust and/or align VLF and site policies (e.g. emergency response, evacuation, spill control)
• Perform internal auditing and inspection • Attend alignment meetings in J&J Campus NL with other biosafety professionals
• Day-to-day support on the shopfloor
Requirements• Academic or equivalent level in the field of biotech/BSO
• Minimum 5 years experience in the field of biosafety
• Experience with GMP and FDA regulations
• Biosafety (minimum BSL-2, MI-III)
• Rules and Regulations in the field of GXP, Environment and GMO’s
• Knowledge of safety aspects and principles such as risk assessments, laboratory safety, disinfection, biocides.
Other informationThis is a role in a GMP production environment, so the ideal candidate is someone who is levelheaded and who can think on their feet in this type of environment. We need a high level of independence and self sufficiency.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
SIRE Life Sciences® is the market leader in life science recruitment. We believe the... recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Rozwiń
- Ostatnia aktualizacja:
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- Pełny etat
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- 2 lata
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Praca Medycyna / Służba zdrowia