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Process Validation Engineer (M/F/D)
Tasks:
This role focuses on ensuring the successful validation of manufacturing DP processes through the development, execution, and reporting of engineering and PPQ (Process Performance Qualification) runs
Protocol Development: Create and standardize Engineering Runs and PPQ Runs protocols in compliance with applicable regulations, quality standards, and project scopes.
Execution Support: Collaborate with and guide the Manufacturing team to ensure smooth execution of validation runs, addressing any technical challenges, and ensuring adherence to protocols.
Documentation & Reporting: Author comprehensive final validation reports, ensuring accuracy, compliance, and integration of all relevant data (e.g., deviations, observations).
Cross-Function Collaboration: Liaise with Quality Assurance, Process Engineering, and other relevant teams to ensure validation activities align with broader manufacturing goals and timelines.
Continuous Improvement: Maintain a focus on optimizing validation processes, leveraging technological and procedural best practices to ensure regulatory compliance and efficiency.
Qualification:
Minimum 3-5 years of experience FF area for recombinant protein.
Engineering or university degree in biotechnology
Language skills: Fluent in English and French
Experience in utilizing Kneat software for validation documentation and processes
Proven expertise in process validation within a pharmaceutical or biotechnological manufacturing setting.
Strong knowledge of Process Validation and Performance Qualification requirements including engineering principles, GMP regulations, and risk management.
Exceptional technical writing skills, facilitating clear, compliant, and detailed documentation.
Ability to work collaboratively across teams and communicate effectively in a high-paced environment.
Problem-solving mindset with attention to detail and commitment to quality.
Requirements:
Start: 16.06.2025
Duration: 5 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland
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