Description
Process Engineer - Manufacturing, cGMP, French contract opportunity to join our Neuchatel based client in the Pharma sector.
Your tasks:
Your experience/knowledge:
Your soft skills:
Location:Neuchatel
Work setting:Hybrid
Sector:Pharma
Start:
Duration:6+ months
Workload:100%
Ref.Nr.:BH 23054
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client
Your tasks:
- 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.
Your experience/knowledge:
- 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.
Your soft skills:
- Excellent comprehension skills with attention to detail
- A high degree of self-organisation and time management
- Analytical and solution-orientated thinking
Location:Neuchatel
Work setting:Hybrid
Sector:Pharma
Start:
Duration:6+ months
Workload:100%
Ref.Nr.:BH 23054
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client