Vacature Life Sciences

CSV ENGINEER - LIFE SCIENCES

Are you eager to ensure the accuracy, reliability and data integrity that may have an impact on public health and safety? Then, TMC is made for you!

| Your challenges?

As a Computerized System Validation Engineer:

• You review the technical documentation related to CSV and carry out the System Impact Assessment of the system.
• You perform the Data Integrity Assessment of the system and build the TM (Traceability Matrix) throughout the project.
• You write protocols, manage and coordinate validation activities (execution of tests and investigation/resolution of potential non-conformities), and write the associated reports.
• You control the maintenance of the validated state of the systems through the Periodic Review activities, in accordance with cGMP over the entire life of the system.
• You ensure the compatibility and the control of data management for each system, guaranteeing their long-term availability according to the requirement for archiving critical data.

| What do we expect from you?

• You have an M.Sc. in Bioscience Engineering or Computer Science.
• You have experience in a computer systems validation role.
• You have a good knowledge of CGMP and specific regulations or guidelines applicable to computerized and automated systems.
• You are autonomous but remain a team-player
• You have a critical mind and good communication skills.
• You are fluent in Dutch and/or French. A good level in English is a plus.

| What can you expect from TMC?

TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world.

At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.

As an Employeneur, you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.

| Why choose for Employeneurship?

We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21st century for high skilled technical professionals. It is built around 5 main pillars:

• You will have a permanent employment contract, offering you stability and security
• You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
• We will support you with one-on-one coaching and training designed to help you develop your entrepreneurial skills
• The competence cells structure provides you with a strong meaningful and relevant network
• The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups

TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.