Process Engineer

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