Validation Specialist
Publication date:
01 March 2025Workload:
100%- Place of work:Bulle
Job summary
Join UCB, a top employer in Switzerland, as a Validation Specialist. Be part of a dynamic team in biopharmaceuticals!
Tasks
- Validate manufacturing and cleaning processes per regulations and needs.
- Provide validation expertise during investigations and projects.
- Lead audits and inspections, ensuring compliance with health standards.
Skills
- Master's in life sciences; experience in validation processes required.
- Fluent in French and English; strong communication skills.
- Proficient in MS Office; critical thinking and adaptability essential.
Summary from the original job ad
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Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: 01.04.2025 (12 months with possible extension)
UCB, one of Switzerland's Best Employers, is an internationally active biopharmaceutical company specialising in the therapeutic areas of neurological disorders and immunology. The Bulle site is home to the company's Swiss sales subsidiary and primarily a biotechnology and chemical production platform for the manufacture and distribution of pharmaceutical specialities for the treatment of allergy, epilepsy and autoimmune diseases.
In order to complete its team, UCB is looking for a Validation Specialist with these following key responsibilities:
- Ensure the validation of manufacturing and cleaning processes in line with the procedures, the regulatory requirements and user needs
- Provide expertise in validation and manufacturing processes knowledge during investigations, Change Controls and projects
- Present the validation/verification documentation during inspections and audits by health authorities and partners
- Implement new processes and support the tech transfer activities for biotechnological and pharmaceutical processes
- Lead cleaning validation/verification, including the definition of the validation strategy and support process validation:
- Drive and write validation risk assessments, change-over protocol and change control for current and new processes as process expert
- Write validation plans, protocols and reports in adherence with planning
- Ensure adherence of the validation activities to the applicable documents (VMP, cleaning verification plan, procedures, guidelines, etc.).
- Participate to the continuous improvement of validation documentation and processes
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Lead validation-related projects within the group
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Participate in technical or organizational cross-functional projects, as well as in specific manufacturing projects for activities related to validation
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Act as SME during projects involving validation activities.
- Work according to cGMP requirements
- Participate in deviations and Change Controls as SME for validation/verification-related subjects, and provide process expertise where needed
- Ensure that all validation/verification documentation (reports, sops…) is up-to-date and inspection-ready
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qualifications
What will make you successful:
- Master's Degree in biology, biotechnology or other lifesciences-related field
- Mandatory experience in biochemical and/or pharmaceutical validation processes
- Documentary experience required (drafting of validation protocols, validation reports, deviations, product VMP / VSR, etc.)
- Fluent in French & English (spoken and written)
- Strong leadership, initiative, and sense of responsibility
- Deep understanding of biotechnological manufacturing processes
- Proficient in MS Office, basic statistical knowledge
- Ability to research, structure ideas clearly, and anticipate issues
- Excellent communicator with internal and external partners
- Skilled at prioritization, stress management, and decision-making
- Solution-oriented, critical thinker, and adaptable under pressure
- Team player with a customer-focused mindset
UCB is committed to fostering a diverse, inclusive and equitable workplace where everyone's talents and perspectives are valued and respected.
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Laetitia Stirer
- Randstad UCB Bulle
