Senior Engineer Product Support – CPV/Trending | Brussels


Function: Sr. Engineer Product Support – CPV/Trending

Report to a Supervisor of the Product Support team (PDS) in the Operations Support Department (OSD).

Objectives:

In your role as Sr. Engineer you will focus on Trending and Continuous Process Verification (CPV) and you will participate in (improvement) projects.

You will join a multidisciplinary team that aims to manage and maintain at Prothya Biosolutions Belgium:

  1. The « Continuous Process Verification » (Trending) program.
  2. The PQR (Product Quality Review)/APR (Annual Product Review) program.
  3. Support Operational activities during deviations.


Main responsibilities and result areas:

In your daily activity, you report to Supervisor of the PDS team which is part of the Operations Support department. 

Your main responsibility will be:

  1. Improve together with the supervisor the CPV approach. Work together with the Amsterdam site and benchmark with partners.
  2. (Co)-lead and/or support projects to improve data gathering and reporting.
  3. Understanding our data/processes and foresee impact of projects/changes on our processes.
  4. Compiling production data (Trend analyses of (Critical) Process parameters and (Critical) Quality attributes, summary reports, …) 
    1. Converting gathered raw data to Minitab;
    2. Analyzing/Interpreting of data, defining process stability and process capability;
    3. Preparation of periodic reports based on all data, such as trending chapter for APR/PQR;
    4. Calculate and evaluate control (alert and action) limits;
    5. Prepare and interpret comparative reports on the intermediate products.
  5. Communicate the result and follow up of your activities with other departments (such as Production, QC, QA) and different hierarchical levels. 
  6. Opening records in het Quality Management System, make investigations and planning for a good follow up. 
  7. Participate in and support deviations, specification documentation, and other team (improvement) projects. Your critical eye and constructive feedback will be an asset.

Profile:

  • Education level: Master (Engineering, Biotechnology, Biochemistry, …) with at least 5 years of experience in a quality-driven sector (pharmacy, food, chemistry …).
  • You have knowledge of statistics and / or continued process verification (trending), experience with Minitab is an asset.
  • Knowledge of quality systems is a requirement, experience with European and American GMP guidelines (Good Manufacturing Practices) and SOPs (Standard Operating Procedures) is an asset.
  • You can set priorities and you are flexible and organizationally strong.
  • You are communicative and enjoy working in a team.
  • You are analytical, result-oriented, and problem-solving.
  • You are customer and service oriented.
  • You have a good knowledge of English (both spoken and written). (Dutch and / or French is an asset)
  • You have knowledge of the MS Office package and other software packages.

Our Company 

Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! 

We offer

Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.

We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).

Furthermore, we value mutual respect and diversity is our strength.

At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!

Are you moving along? Then apply now!


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