Engineer Process Equipment
For our client, Janssen Vaccines & Prevention, we are looking for an Engineer Process Equipment.
Would you like to be the person that is helping us realizing novel vaccines for the world? Continue reading, we would like to get in contact!
The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where they produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV, and Ebola. This is also the place where they are producing the batches of COVID-19 vaccine material.
To strengthen the Operations Support Team within DSO we are looking for an Engineer Process Equipment to helps the department prepare for the future requirements for data integrity compliance.
The Engineer process equipment is the first point of contact with Engineering, Validation, and Maintenance (EVM) and Quality Assurance (QA) for data integrity compliance matters: eg. user access, audit trails, data processing and backup and training. Together with the development teams, QA and EVM, you will identify gaps and implement measures to improve these sub-topics (in sync with cGMP regulations). The ultimate task is to assure equipment is available at all times to allow smooth and compliant operation activities.
- Be the expert about equipment data integrity topics in a cGMP environment ;
- Lead to assure the availability of compliant equipment and processes in the department;
- Support troubleshooting and investigation in non-conformances (process and equipment related);
- Lead and support process excellence activities to continuously improve the work.
Who we're looking for
For this role we are looking for a BSc. (HBO) candidate with at least 5 years of experience in the pharmaceutical industry/biotechnology (cell culture equipment, downstream process equipment, etc.). Experience with cGMP and EHSS standards is required as well as experience with handling change controls, deviations, risk assessments, etc. Lean Green Belt certification is preferred.
Additionally, you have good Quality Assurance understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance and engineering (e.g. GMP, NEN 3140, VCA, CE). You have strong affinity with computerized systems and equipment data flows
As a person, you have a good eye for 'the bigger picture', you are flexible and stress-resistant and remains positive when priorities change. Are you the independent team player we are looking for?
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
The department DSO is an international team of about 50 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA, and warehouse. Our passion is to deliver high-quality results to our customers and to seek opportunities for improvement: never a dull moment!
Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing, and the Operations Support Team. The teams are responsible for their cGMP status by regular equipment care, maintaining the documentation system, reporting quality issues, and performing the resulting corrective actions, training, and inspection readiness.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >3700|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.