One of our leading Biotech clients has an opening for a Process Engineer in Leiden. We are looking for someone who has experience with manufacturing process verification and new material introduction in a GMP environment
Leiden site Technical Operations (TO) is part of the global Technical Operations organization. TO is responsible for validation and standardization of processes and equipment within the company’s site and manages Life Cycle Management (LCM) projects and improvement projects.
Technical Operations is responsible to execute the polymeric risk assessment for new incoming materials and supplies based on vendor availability. Materials and supplies being used in manufacturing process will be updated and replaced based on vendor availability, therefore
- Responsible for writing continued verification process reports. This includes:
- Data gathering, data analysis and reporting out the data.
- Updating CPV procedures when needed and troubleshooting data excursions when needed.
2) In the new material introduction project team:
- Introduction of new filters, tubing, containers etc.
- responsible for writing product contact processing material assessments, including:
- Writing/reviewing leachable and extracable assessments
- Minimal Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering)
- Affinity with manufacturing processes, ideally with monoclonal antibody manufacturing processes.
- Experience with writing assessments of product contact processing materials.
- Minimal 5 year relevant experience in the (bio-) pharmaceutical industry;
- Proven experience with GMP and compliance
- Proven statistical knowledge and experience
- Flexible and agile in fast responding to change in requests
- Good communicative skills in English language (writing and verbal), Dutch is a plus
PROJECT START DATE
If you are interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Ralph Looijen at +31 (0)20 20 44 502 or by email at email@example.com