We are looking for a Process Engineer with a background in GMP manufacturing who will work on Continued Process Verification to be a part of the new material introduction project team e.g introduction of new filters, tubing, containers etc.
The Technical Operations department of our client Janssen Biologics is responsible for validation and standardization of processes and equipment within the site. Technical Operations is responsible for the execution of the polymeric risk assessment for new incoming materials and supplies based on vendor availability. Materials and supplies being used in manufacturing process are updated and replaced based on vendor availability. To support the team we We are looking for someone who has affinity with manufacturing processes & statistics, ideally with pharmaceutical monoclonal antibody manufacturing processes.
- Responsible for writing continued verification process reports. This includes
- data gathering, data analysis and reporting out the data.
- Updating team procedures when needed and troubleshooting data excursions when needed.
- Responsible for writing product contact processing material assessments, including writing/review leachable and extricable assessments
- Minimal Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering)
- Minimal 5 year relevant experience in the (bio-) pharmaceutical industry;
- Proven experience with GMP and compliance
- Proven statistical knowledge and experience
- Analytically strong, precise, and structured work approach
- Collaborator; easy in making connections between people. Like to find her/his way in a virtual organization
- Eager to learn something new
- Flexible and agile in fast responding to change in requests
- Good communicative skills in English language (writing and verbal), Dutch is a plus
- Contract: initially through Oxford untill end-of year, possibility to extend;
- Salary: €3500- €4000 gross monthly based on education/ experience;
- Holidays: 25 (+12)
- Remote possibilities: Initially fully remote due to Covid restrictions later (partial) on site presence is required ;
- Working hours: full-time, 32 hours discussable
- Region: Leiden
- Vacancy number: 17440
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As a specialist company we have a wide range of laboratory vacancies in Quality Control (QC) and Research & Development (R&D) within various sectors, including Pharmaceuticals, Biotechnology, Contract Manufacturing, Contract Research, Food Industry, Chemicals, Environment and Plants.
Oxford is always looking for talent with expertise in Biotechnology, Immunology, Biochemistry, Virology, Microbiology, Molecular Biology, Life Science, Analytical Chemistry, Physical Chemistry, Polymer Chemistry, Petrochemistry and Diagnostics. We are keen to meet candidates who have experience in one or more of the following techniques: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, virus culture, cell culture, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, cloning, sequencing, protein purification, purification, HPLC, UPLC, chromatography, physical chemistry, viscosity, melting point, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titrations, Karl Fisher, formulation, sterility, determinations, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.
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