job details
summary.
- Neuchatel, Neuchâtel
- Temporary
- specialismengineering
- contactMarta Tomczyk
- reference number22841
speed up the application by sharing your profile
General Information:
- Start date: 06.01.2025
- End date: 31.12.2025
- Workplace: Neuchâtel
- Workload: 100%
- Home office: possible up to 3 days per week, but during the first 2-3 weeks onsite presence required full time
Tasks and responsibilities:
- Lead process improvement projects or activities
- Develop and optimize process parameters
- Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
- Identify business opportunities
- Ensure communication and act proactively in case of performance trending
- Lead and/or support investigations related to deviation/CAPA process
- Perform product impact assessment for deviation
- Lead projects or activities related to FF process or equipment (from User Requirements Specifications to Process Performance Qualification)
- Support validation activities
- Support or present topic during regulatory inspections
- Support technology transfer
45% - Manufacturing support activities (deviation, process follow-up)
45% - Projects
10% - Audit and Regulatory questions related activities
Your profile:
- Minimum 3-5 years of experience FF area for recombinant protein
- Previous MSAT exposure
- Engineering or university degree in biotechnology
- Language skills: Fluent in English and French
- Knowledge of cGMP and quality requirements
- Able to deal with statistics
- Strong energetic team player with good communication skills
- Ability to lead effectively and efficiently process validation topics
- Ability to manage multiple priorities in a manufacturing plant setting
- Ability to analyze, review and interpret validation data
- Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
- Interpersonal skills that enables you to work with people at all levels
- Ability to plan, multitask, and manage time effectively
- Must display eagerness to learn, to innovate, drive for solutions and continuously improvement
- Able to deal in a matrix environment as well manage complex problem
General Information:
- Start date: 06.01.2025
- End date: 31.12.2025
- Workplace: Neuchâtel
- Workload: 100%
- Home office: possible up to 3 days per week, but during the first 2-3 weeks onsite presence required full time
Tasks and responsibilities:
- Lead process improvement projects or activities
- Develop and optimize process parameters
- Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
- Identify business opportunities
- Ensure communication and act proactively in case of performance trending
- Lead and/or support investigations related to deviation/CAPA process
- Perform product impact assessment for deviation
- Lead projects or activities related to FF process or equipment (from User Requirements Specifications to Process Performance Qualification)
- Support validation activities
- Support or present topic during regulatory inspections
- Support technology transfer
45% - Manufacturing support activities (deviation, process follow-up)
45% - Projects
10% - Audit and Regulatory questions related activities
Your profile:
- Minimum 3-5 years of experience FF area for recombinant protein
- Previous MSAT exposure
- Engineering or university degree in biotechnology
- Language skills: Fluent in English and French
- Knowledge of cGMP and quality requirements
- Able to deal with statistics
- Strong energetic team player with good communication skills
- Ability to lead effectively and efficiently process validation topics
- Ability to manage multiple priorities in a manufacturing plant setting
- Ability to analyze, review and interpret validation data
- Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
- Interpersonal skills that enables you to work with people at all levels
- Ability to plan, multitask, and manage time effectively
- Must display eagerness to learn, to innovate, drive for solutions and continuously improvement
- Able to deal in a matrix environment as well manage complex problem
get in touch.
we are here to help you with your questions.
Marta Tomczyk
- +41 58 201 55 50
- Basel Professionals IT & Life Sciences
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