Engineer Process Support Validation

Function: Engineer Process Support – Process Validation

Report to the Supervisor of the Process Support team (PCS) in the Operations Support Department (OSD).

Objectives:

In your role as Engineer you will focus on Process Validation, identification and mitigation of gaps in production, implementation of improvements, and problem solving via our quality system (CAPA, Change Control management).

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

• The validated status of the current GMP manufacturing processes and all required documentation.
• The Expertise in the different manufacturing processes, holding time, cold chain, Leachables and Extractibles.
• Support Operational activities during deviations/investigations.

Main responsibilities and result areas:

In your daily activity, you report to the Supervisor of the PCS (Process Support) team which is part of the Operations Support department.

Your main responsibility will be:

• Perform process validations and any compliancy in this field.
• Write documents linked to process validation such as:
• Protocols and reports (PPQ or Process Verification);
• FMEA / Risk Assessments.
• (Co)-lead and/or support projects to improve and maintain the compliance to the guidelines of the current manufacturing processes.
• Understand our manufacturing processes and foresee impact of projects/changes on our processes.
• Communicate the result and follow up of your activities with other departments (such as Production, Engineering, QA) and different hierarchical levels.
• Manage records in the Quality Management System (such as CAPA or Change control), make investigations and planning for a good follow-up.
• Participate in the root cause analysis of process deviations (when needed), 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 3 years of experience in a quality-driven sector (pharmacy, food, chemistry …).
• 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.
• Knowledge of the processes relating to plasma derivatives and the techniques used at Prothya Biosolutions Belgium (UF-DF/chromatography, precipitation, cleaning, etc.) is an asset.
• You are able to write technical documents such as protocols, reports and risk assessments.
• 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