Validation Engineer - Manufacturing Process Expert
We are seeking an experienced Validation Engineer to join our Life Sciences team in Neuchâtel, Switzerland. The ideal candidate will have a strong background in process validation and be able to manage the validation of manufacturing processes through the development, execution, and reporting of engineering runs and PPQ (Process Performance Qualification) runs.
* Key Responsibilities:
* Protocol Development: Create and standardize protocols for Engineering Runs and PPQ Runs in compliance with applicable regulations and quality standards.
* Execution Support: Collaborate with the Manufacturing team to ensure smooth execution of validation runs and address any technical challenges.
* Documentation & Reporting: Author comprehensive final validation reports, ensuring accuracy and compliance with all relevant data.
* Cross-Function Collaboration: Liaise with Quality Assurance, Process Engineering, and other teams to ensure alignment with broader manufacturing goals and timelines.
* Continuous Improvement: Maintain a focus on optimizing validation processes, leveraging best practices to ensure regulatory compliance and efficiency.
Required Skills and Qualifications:
* Minimum 3-5 years of experience in the pharmaceutical or biotechnological manufacturing setting.
* Engineering or university degree in Biotechnology.
* Fluent in English and French language skills.
* Experience in utilizing Kneat software for validation documentation and processes.
* Proven expertise in process validation, including knowledge of Process Validation and Performance Qualification requirements.
* Strong technical writing skills, with ability to facilitate clear and compliant 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.
Benefits:
* A dynamic team environment with opportunities for professional growth and development.
* A human accompaniment and follow-up of your career development.
* Challenges to contribute to the development of your network.
* A company certified @HappyAtWork with a committed CSR policy.
Seniority Level: Associate
Employment Type: Full-time
Job Function: Engineering and Consulting
Industries: Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research