Senior Validation Engineer

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

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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.

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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.

• 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.