Validation Specialist.

dettagli di lavoro

dettagli offerta.

  • categoria
    costruzione
  • Contatto
    Laetitia Stirer
  • riferimento
    209836-202

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dettagli di lavoro

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

  • 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

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

  • 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

lavorando presso ucb farchim

luogo di lavoro

1630 Bulle, Fribourg

UCB Farchim

contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

LS

Laetitia Stirer

  • Randstad UCB Bulle

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