We are looking for a Validation Engineer. You will be working in our newest plant where we make products for the healthcare market.
A new plant for the production of cell culture media is being built at our location in Tilburg. Cell culture media are raw materials for the biopharmaceutical industry, where they are used for the production of medicines or vaccines. For this new production facility we have a vacancy for a Validation Engineer in the department Quality Systems / Regulatory Affairs (QS/RA).
Within Life Science Manufacturing (LSM), the QS/RA department is responsible for all activities relating to quality. This includes the approval of raw materials, the release of finished products and all tests on these materials, but also supplier evaluations, deviations during production and change control. Document control also falls under this department. As Validation Engineer, you are responsible for carrying out and setting up various validations; both on equipment and for various processes and production. In addition, you support the writing of procedures and protocols for this. You are also involved in the evaluation of existing processes and in change control, deviations and CAPAs around validations. Together with the validation specialist, you are responsible for ensuring that all equipment, utilities and processes are and remain in a validated state.
- A completed HBO education in a chemical, biological, pharmaceutical or (process) engineering field;
- 2-4 years of experience in performing and preferably setting up validations in the medical, pharmaceutical, biotechnological or other regulated industry. For example in the field of equipment and utilities qualification, cleaning validation, process validation, temperature mapping, computer system validation etc.;
- Knowledge and understanding of validation guidelines and ISO and GMP guidelines;
- Good command of the Dutch and English language verbally and in writing;
- For employment, a Certificate of Good Behaviour must be submitted.
We are looking for
A colleague who feels strongly about quality. You are critical, analytically strong and able to communicate constructively with various stakeholders. You are disciplined in working according to fixed protocols. After a short familiarisation period, you are able to carry out your tasks independently. Working in a team is also something you do well. The start-up of a new department goes hand in hand with hectic activity, deadlines and possibly changing priorities. You are able to deal with this and ensure that your work is carried out as agreed.
Where are you going to work
FUJIFILM Manufacturing Europe B.V. is one of the largest Fujifilm production sites outside Japan. Here, with around 700 employees, we are responsible for the production of photographic paper, offset plates and membranes. A new factory for cell culture media is currently being built in Tilburg. The Tilburg Research Laboratory is also located here, where we work on the development of new products and technologies. Part of the European headquarters is also located in Tilburg. This company is responsible for, among other things, purchasing, finance, IT, logistics and customs matters.
The Quality Systems / Regulatory Affairs department currently consists of 10 people. The Life Science Manufacturing department is a growing organisation and so will the QS/RA department in the future.
At Fujifilm, our employees are our most important asset. We want people to feel at home in our company. We provide good working conditions and look to develop talent. We also invest in training, consider development opportunities and think about the future as an annual theme within our personnel policy.
We also offer:
- A 40-hour work week with the possibility of arranging your working hours flexibly;
- An above-average salary, depending on education and experience;
- A good bonus scheme;
- 27 holiday days;
- 12.5 ATV days;
- A travel and expense allowance;
- A good pension scheme;
- A collective health insurance;
- Good training and development opportunities;
- And nice other secondary benefits such as participation in the bicycle plan or discount on trips.
You will be based in Tilburg.
Would you like to increase your career opportunities within an innovative, high-tech and international company? Send your CV and motivation stating "RA-1036 Validation Engineer" to firstname.lastname@example.org.
If you have any questions, please contact Heidi Franken, Sr. Supervisor at +31(0)6 5237 4182 or visit www.fujifilm.com/ef/nl for more information about our organization.
Acquisition in response to this vacancy is not appreciated.