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Technical Expert Bioassay Equipment

Technical Expert Bioassay Equipment

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a Technical Expert Bioassay Equipment.

Keywords
  • Statistical data analysis
  • Equipment introduction
  • TECAN robotics
  • GMP

In this job, you will actively handle the quality and compliance related issues especially related to equipment (Pipetting robot (TECAN), plate-reader etc.). You act as Subject Matter Expert (SME) during cGMP inspections and are responsible in planning and implementing these tools. You will have to create and maintain a long term (financial) plan for the equipment. Bring in new technologies and are responsible for automating of some of the pipetting work. You will be part of our team to maintain cGMP compliance and LEAN status of the team.
Key responsibilities:
1. Equipment and new technology:
  • Coordinating activities related to equipment qualification and maintenance;
  • Generating a long-term plan to meet future needs on required equipment (including financial plan) and follow up with stakeholders, making sure there is enough place and equipment to test future needs and that the lab lay-out is efficient to work in;
  • Coordinating TECAN (pipetting robot) activities, making sure new scripts are being qualified and TECAN is most efficiently used;
  • Setting-up URS’s (user requirement settings) in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team;
  • You are connecting and scouting new technologies that could benefit the department. Checking and designing how the new technology could be implemented in the department within the GMP environment;
  • Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines;
  • Ensure that assays can technically be carried out by the departments concerned in a manner that is efficient, adheres to cGMP and is safe. This could be accomplished by means of the GAP analysis performed during the new product implementation;
  • Leads and drives continuous improvement processes;
  • iLabs roll out in 2022 – coordination of digitalization of ASSAY run sheets in eLIMS (nice to have).

2. Deviation Management:
  • Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions;
  • Supervise timely closure of medium/high-level investigations and associated CPA’s;
  • Supporting and advising other lead investigators from external and internal QC departments;
  • Accurate lab investigation and CPA’s for the medium/high-level Quality issues.

Profile

The ideal candidate has a BSc. or MSc. candidate with 5 years relevant working experience. You have knowledge of statistical data analysis and equipment introduction. Experience with TECAN and working in a GMP environment are a strong plus. Additonally, you have good organizational skills in order to optimally coordinate a project.

Benefits

Contract for at least one year. 32-40h per week. 2 days work from home is possible.
Salary: > 3150
Days of leave: 36
See here our other employment terms for this vacancy

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Bioassay test team is responsible for execution of test methods using various biological techniques (e.g. ELISA, PCR, Cell Culture, Bioassays). Samples ranging from early clinical up to commercial process control, release and stability.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Technical Expert Bioassay Equipment

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