Manufacturing Associate

Location: Netherlands

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 organisation, based in Zuid-Holland Netherlands.

The Company

This company is committed to developing first-in-class or best-in-class vaccines for some of the world's most life-threatening infectious diseases. They have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden they have a workforce of 700 scientists and support staff, 45% of their employees have a nationality other than Dutch with over 20 nationalities represented. They partner with many of the world's leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example: Ebola and HIV.

In their organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central point. In order to strengthen our team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company.

Role Description

You will perform your daily task within the Operations Bio processing Department.

Within Bio-processing the emphasis will be on the primary production processes (from the protein line till (pre)Formulated Bulk) you will support processes like: Media preparation, buffer preparation and equipment preparation.

As a Manufacturing Associate you will handle and support multiple requests from a diversity of areas like EHS&S, GMP, operational requests. And support the Manufacturing Process Specialists staff in introducing, maintenance and improvement of the production equipment and processes. Proficiency in the core tasks but also willing to specialize in other work areas if necessary. You are able to carry out assignments independently

Responsibilities

- Supporting Manufacturing Process Specialists with the introduction of new processes and systems, and the maintenance of existing processes and systems
- Ensure adequate documentation to support existing process and systems e.g. Periodic Review, preparation and adjustment of SOP's and work instructions
- Independently handling and supporting Manufacturing Process Specialists with help request in the areas of EHS&S, GMP and production
- Making sure that all the activities are compliant with the requirements of CGMP and the EHS&S guidelines
- Preparation and adjustment of operational documentation (SOP's and WIs) in DocSpace
- Reviewing documentation from others
- Acts as a first point of contact for the department and screens incoming requests, hereby deemed to be able to decide whether to handle it themselves or to continue to the next layer
- Preparation of technical documentation (protocols, reports, memoranda)
- Independently collecting data from the various systems and intercepting and analyzing the data for the Periodic Review report
- Support Change controls; collects data for deviation control
- Draws up training material and procedures

Requirements

- Experience with documentation and data
- Bachelors' degree, technical or pharma related
- Basic understanding of GMP environment and safety compliance
- Affinity with process systems
- Flexible, enthusiastic, inquisitive

Other information

- Knowledge of cGMP, EH&S and Lean is considered a plus
- Experience with MES (Manufacturing Electric System)/DocSpace/SAP/Quality or Deviation Central Systems is a plus

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Helene de Vries