- Lead process validation and cleaning validation/verification, including the definition of the validation strategy:Drive and write validation risk assessments, change-over protocols and change controls for current and new processes,Write validation plans, protocols, and reports.
- Provide expertise in validation and process knowledge during investigations, Change Controls, and projects for biological processes.
- Implement new processes and support the Tech Transfer activities for biological processes.
- Lead and ensure the implementation of CPV for new processes:Definition of the initial CPV plan & creation of the initial CPV report,Lead complex CPV investigations.
- Act as a Subject Matter Expert (SME) for selected topics such as Process Validation, Cleaning Validation, CPV, etc.
- Master's degree in a relevant Life Sciences engineering discipline and 3+ years operational experience in chemical or pharmaceutical manufacturing,
- Proven experience in multiproduct facilities, process validation and cleaning validation,
- Able to work in a GMP environment, with a strong manufacturing mindset,
- Ability to scope, research and understand complex subjects related to chemical & pharmaceutical manufacturing,
- High capacity to anticipate issues, identify priorities and make decisions,
- High level of autonomy and good stress management skills.
- Excellent communication skills, fluent in French and English and capable to create a strong relationship with business partners and stakeholders.
Process Expertise - Bulle, Schweiz - UCB
Beschreibung
Make your mark for patients
We are looking for a Process Expertise & Validation Specialist who is analytical, innovative and team player to join us in our Process Expertise & Validation team, based in our site office in Bulle , Switzerland.
About the role
As a Process Expertise & Validation Specialist you will support process and cleaning validation for the chemical & pharmaceutical processes (i.e. for our Allergy and Neurology products), and provide process expertise during investigations, Change Controls and projects.
Who you'll work with
You will work in a team of ~10 colleagues who share a very collaborative spirit.
What you'll do
I nterested? For this role we're looking for the following education, experience and skills
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you