SIRE Life Sciences®

Sr Operator

Location: Leiden, Netherlands
The Company 
This organization focuses on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases.

Role Description 
Executing and documenting clinical trials materials (CTM) production according to planning and cGMP regulations. 

Responsibilities
- Production activities of cGMP batches. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
- Ensures accurately completion of documentation such as batch records, logbooks, etc.
- Working precisely, detecting and solving acute problems and communicate possible abnormalities.
- Provides solutions to problems of moderate scope of complexity.
- Preparing, assemble and disassembly of process equipment for production activities.
- Write and updating protocols, test methods, standard operating procedures and batch documentation.
- Collects, analyzes, and compiles data. Summarizes data for interpretation by supervisor
- Practical realization of the development (experiments and tests) under the supervision of scientist(s) and in line with procedures (GLP, SOP, LSN –laboratory solution number-, LSS –laboratory solution sheet)
- Operates and maintains laboratory equipment; operates hands-on analytical and other instruments considered standard in their area of expertise
- Implementation of new techniques 
- Deviation investigation and follow up
- Write documentation and perform training of new operators. 
- Guide department and operational team in use of PE tools as well as GMP 


Requirements 
- HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology
- Expert in cell culture (USP), virus propagation and / or downstream processing (DSP)
- Experience with change controls, non-conformances and CAPA records
- Experience with cGMP and EHSS standards is required
- Lean green belt certification is preferred


Other Information 
6 months + extension expected. 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 
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SIRE Life Sciences®

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