Senior Validation Engineer Brussel (BE)

Vacature in het kort

Seeking a Senior Validation Engineer to spearhead qualification and validation activities in a pharmaceutical setting, focusing on Performance Qualification for various systems. You'll lead PQ activities, validate cleaning and sterilization processes, ensure accuracy in vial filling, oversee automation system validation, and execute clinical manufacturing process confirmation runs. This role involves managing project documentation, training team members, and ensuring compliance with regulatory standards. Read on to learn why this position could be your next career move.

Volledige vacaturetekst

Do you have experience leading complex validation projects and optimising pharmaceutical manufacturing processes?

-

We are looking for a Senior Validation Engineer to lead the qualification and validation activities, specifically Performance Qualification (PG), for various systems and processes within a pharmaceutical facility to ensure they meet all required specifications, quality standards, and regulatory guidelines. 

-

Tasks & responsibilities:

• Lead the preparation and execution of PQ activities for clean utilities, facility environmental monitoring, and temperature control units.
• Conduct validation of cleaning processes and sterilisation cycles, including autoclaves and part washers.
• Validate vial filling accuracy and decontamination processes in pharmaceutical production environments.
• Oversee the validation of automation systems (Computer System Validation - CSV) and media simulation/fill activities.
• Execute process confirmation runs for clinical manufacturing, including water batches and engineering runs.
• Update and maintain project documentation following quality standards and project guidelines.
• Train and guide team members on PQ processes and compliance requirements.
• Manage deviations and changes, ensuring all activities comply with regulatory standards and achieve project milestones.

Gevraagd

• Bachelor's or Master's degree in a relevant field.
• Extensive experience in performance qualification verification strategies and testing within the biotechnology industry.
• Profound knowledge of risk-based approaches to commissioning and qualification, familiar with ISPE, GAMP-5, Annex 15 of EU GMP, ASTM E2500, and electronic execution. 
• Expertise in biotech processes, ideally including downstream/upstream processing and gene therapy rAAV.
• Experience in commissioning and qualifying single-use technologies and automation in the pharmaceutical/biotechnology industry.
• Strong understanding of applied statistics, quality systems, and regulatory requirements across multiple health authorities. 
• Ability to write and review technical documentation clearly and comprehensively.
• Proven project management skills in a cross-functional, multi-site environment.
• Knowledge of pharmaceutical analytical testing standards.
• Experience with sterile, biotech, or single-use equipment in the biopharmaceutical industry.
• Understanding of safety, GMP, and environmental regulatory requirements.
• Excellent decision-making skills under pressure and effective communication and leadership abilities.
• Proficiency in English, with strong interpersonal and initiative-taking capabilities.