Validation Specialist
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Job Location:
La Gruyère - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Make your mark for patients
We are looking for aValidation Specialist who is eager to join our Internal Manufacturing department based on our production site in Bulle Switzerland.
About the role
As Validation Specialist you will ensure the validation of manufacturing and cleaning processes is in line with procedures regulatory requirements and user needs. You will ensure adherence to the site Validation Master Plan provide expertise in validation and manufacturing processes during investigations change controls and projects and present validation/verification/CPV documentation during inspections and audits.
Who youll work with
You will collaborate with manufacturing teams quality assurance internal and external laboratories the Analytical Validation team and cross-functional project groups. You will also interact with health authorities and partners during audits and inspections.
What youll do
- Support and/or coordinate process and cleaning validation/verification activities including defining validation strategies.
- Drive and write validation risk assessments and change controls for current and new processes.
- Write validation plans protocols and reports in adherence with planning.
- Coordinate sampling and analyses with manufacturing teams and laboratories.
- Lead the implementation and ensure compliance of Continued Process Verification (CPV) for current and new processes.
- Participate in continuous improvement of validation documentation and processes.
- Lead validation-related projects and participate in technical or organizational cross-functional projects.
- Work according to cGMP requirements.
- Participate in deviations and change controls as SME for validation/CPV/verification-related subjects.
- Ensure all validation/CPV/verification documentation is up-to-date and inspection ready.
- Actively promote and respect HSE policy and processes.
- Integrate UCBs ambitions for inclusion business health management environmental policy ethics compliance and patient value culture into daily responsibilities.
Interested For this role were looking for the following education experience and skills
- Masters or Ph.D. in a relevant technical field.
- High understanding of biotechnological manufacturing processes.
- Ability to scope research and understand complex subjects related to biotech manufacturing.
- Ability to structure ideas quickly and clearly.
- Excellent organization and problem-solving skills.
- Strong leadership skills.
- Good proficiency with MS Office tools.
- Basic knowledge of statistics.
- Excellent communication skills for internal and external partners.
- Ability to define objectives and how to reach them.
- High capacity to anticipate issues identify priorities and make decisions.
- High level of autonomy and good stress management skills.
- Solution-oriented and sensitive to customer needs.
- Pragmatic and critical-minded.
- Sense of responsibility ownership and initiative.
- Team player.
- High level of spoken and written French and English.
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 over 9.000 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats 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.
At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more
