Engineer Product Support – CPV/Trending| Brussels
Function: Engineer Product Support – CPV/Trending
Reports to a Supervisor of the Product Support team (PDS) in the Operations Support Department (OSD).
Objectives:
In your role as an Engineer, you will focus on Trending and Continuous Process Verification (CPV) processes, and you will participate in improvement projects.
You will join a multidisciplinary team that aims to manage and maintain at Prothya Biosolutions Belgium:
- The “Continuous Process Verification” (Trending) program
- The PQR (Product Quality Review)/APR (Annual Product Review) program
- 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:
- Work together with the PDS supervisor to enhance the CPV approach and compliance reporting, while (co-)leading and supporting projects aimed at improving data gathering and reporting
- Understanding our manufacturing data/processes and foresee impact of projects/changes on our processes
- Compiling and analysing production data
- Performing trend analyses of (Critical) Process Parameters and (Critical) Quality Attributes and preparing summary reports
- Converting raw data into Minitab for statistical calculations
- Analysing and interpreting data to assess process stability and process capability
- Preparing periodic reports based on all compiled data, including trending sections for APR/PQR
- Calculating and evaluating control limits (alert and action limits)
- Preparing and interpreting comparative reports for intermediate products. Communicate the result and follow up of your activities with other departments (such as Production, QC, QA) and different hierarchical levels
- Opening records in the Quality Management System, conducting investigations to ensure proper follow-up and effective planning
- Support and participate in deviations, specification documentation, and other team improvement projects. Your critical eye and constructive feedback will be an asset
Profile:
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, (Bio)chemistry, Computer Science or a related field, with a minimum of 2 years of experience in a quality‑driven industry (e.g., pharmaceutical, food, chemical sectors)
- Strong knowledge in statistics and/or continued process verification (trending). Experience with Minitab is considered an advantage
- Solid understanding of quality systems is essential. Familiarity with European and U.S. GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is an asset
- Able to set priorities effectively, demonstrating flexibility and strong organizational skills
- Facilitates clear communication and drives collaboration within the team and across other teams
- Analytical thinking, with a result‑oriented and problem‑solving mindset
- Strong customer and service orientation
- Proficient in English (spoken and written). Knowledge of Dutch and/or French is an advantage
- Proficient in MS Office and other relevant 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!