- 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.
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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
Interested? For this role we're looking for the followingeducation, experienceand 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
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
