Process Engineer (Process Validation Engineer Fill & Finish)
On behalf of our Pharmaceutical client in Neuchatel, we are looking for a Process Validation Engineer. The main role will include DP Process Validation of a new Filling Line.
General Information :
Client : Pharmaceutical
Location : Neuchatel
Start Date : 16.06.2025
Duration : 6 Months
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.
Responsibilities :
* 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.
* 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.
Recruitment Contact : Elaine Kanwar +41 61 282 2223
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