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
Lead validation-related projects within the group
Participate in technical or organizational cross-functional projects, as well as in specific manufacturing projects for activities related to validation
- 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
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
Lead validation-related projects within the group
Participate in technical or organizational cross-functional projects, as well as in specific manufacturing projects for activities related to validation
- 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
