Validation Engineer Pharma | Brussels
il y a 2 jours
Engineer Process Support - Process Validation | Brussels Join to apply for the Engineer Process Support - Process Validation | Brussels role at Prothya Biosolutions Direct message the job poster from Prothya Biosolutions Overview Function: Engineer Process Support – Process Validation. Reports to the Supervisor of the Process Support team (PCS) in the Operations Support Department (OSD). Objectives: In this role you will focus on Process Validation, identify and mitigate gaps in production, implement improvements, and solve problems via our quality system (CAPA, Change Control management). You will join a multidisciplinary team that manages and maintains at Prothya Biosolutions Belgium: The validated status of the current GMP manufacturing processes and all required documentation. Expertise in the different manufacturing processes, holding time, cold chain, Leachables and Extractibles. Main responsibilities and result areas 1. Perform process validations and ensure compliance in this field. 2. Write documents linked to process validation such as protocols and reports (PPQ or Process Verification). 3. (Co)-lead and/or support projects to improve and maintain compliance with current manufacturing process guidelines. 4. Understand manufacturing processes and foresee impact of projects/changes on processes. 5. Communicate results and follow up of activities with other departments (Production, Engineering, QA) and different hierarchical levels. 6. Manage records in the Quality Management System (CAPA, Change control), conduct investigations and plan follow-up. 7. Participate in root cause analysis of process deviations (when needed) and other improvement projects. Provide a critical eye and constructive feedback. Profile and qualifications Education: Master (Engineering, Biotechnology, Biochemistry, ...) with at least 3 years of experience in a quality-driven sector (pharmacy, food, chemistry ...). Knowledge of quality systems; experience with European and American GMP guidelines and SOPs is an asset. Knowledge of processes relating to plasma derivatives and techniques used at Prothya Biosolutions Belgium (UF-DF/chromatography, precipitation, cleaning, etc.) is an asset. Ability to write technical documents such as protocols, reports and risk assessments. Flexibility and organizational strength. Communicative and team-oriented. Analytical, result-oriented, and problem-solving mindset. Customer and service oriented. Good knowledge of English (spoken and written); Dutch and/or French is an asset. Knowledge of MS Office and other software packages. We offer Prothya Biosolutions Belgium is part of an international biopharmaceutical group offering long-term career perspectives and on-the-job training. Competitive salary, group and health insurance, meal vouchers, eco-cheques, and a Flex Reward Plan (voluntary benefits). Attractive holiday system exceeding legal holidays and homeworking after onboarding. Mutual respect and diversity as a strength. Engagement means initiative; all colleagues contribute to annual objectives and future success. Do you move with us? Then apply now Job details Seniority level: Associate Employment type: Full-time Job function: Engineering, Manufacturing, and Production Industries: Chemical Manufacturing and Food and Beverage Manufacturing Referrals increase your chances of interviewing at Prothya Biosolutions. Get notified about new Validation Engineer jobs in Brussels, Brussels Region, Belgium. #J-18808-Ljbffr
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