Validation Manager
Location: GermanySIRE 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. 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!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Hessen Germany.
Our client is manufacturing BioPharmaceuticals in the Hessen area.
ROLE DESCRIPTION
- Cleaning /Process Validation Protocols and Reports for assigned Products
RESPONSIBILITIES
- Validation system (i.e., policies, procedures, training, etc.) and maintain a database
- Validation activities with an emphasis in risk-based, science-based approaches to Process Validation (QbD) and to cGMP
- Troubleshoot cleaning validation / process validation
- Regulatory inspections by presenting validation strategies
- Collaborate with stakeholders, Qualification, Production, R&D, QC staff and others
- Maintain knowledge relating to validation activities with an emphasis in cGMP.
REQUIREMENTS
- Degree (Bachelor, Masters or higher) in Life Sciences (Biology, Chemistry, etc.) or related
- Experience preferably gained within the process/cleaning validation environment ideally on a Life Sciences manufacturing site
- Experience and knowledge in biotech or pharmaceutical manufacturing processes
- Proven experience in cGMP, GLP & cGxP
- Fluency in German and English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.
