Validation Engineer
Location: NetherlandsSIRE 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 Noord-Brabant Netherlands.
The company is a well-known international bio/pharma organization.
ROLE DESCRIPTION
Area of Interest Project Manager:
• Pharma Controlled Temperature mapping
• Pharma Secondary Packaging, including MES and Serialization
Contribution
Contributes to work group/team by ensuring the quality of the tasks/services provided by self
Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup
Establishes working relationships with others outside area of expertise
RESPONSIBILITIES
• Provide validation impact assessment for change requests.
• Participate in ABR projects and improvement efforts.
• Provide solutions to a variety of highly complex technical validation problems of large scope.
• Independently evaluate, select and apply standard validation engineering techniques, procedures and criteria.
• Perform validation assignments that have loosely defined objectives that require investigation of a large number of variables.
• Interpret and execute policies and procedures.
• Function as a technical validation expert to resolve complex validation problems.
• Lead efforts with other disciplines in developing requirements and recommendations for system modifications.
• Execute tasks under the general supervision of project managers to complete the validation responsibilities of projects within schedule and budget constraints.
REQUIREMENTS
- Understanding and application of principles, concepts, theories and standards of validation field
- Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations and compliance
- Experience with secondary packaging is strongly preferable
- Experience in a GMP/strongly regulated environment
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rosa Markus.
