Process Validation Specialist

vor 2 Wochen


Bern, Bern, Schweiz Agap2 - HIQ Consulting AG Vollzeit

At Agap2 - HIQ Consulting AG, we are seeking a skilled Process Validation Specialist to join our team. As a Process Validation Specialist, you will play a crucial role in the integration of new production equipment and utilities in a biotech/pharma/medtech environment.

About the Job

In this position, you will be responsible for creating specifications (URS) and risk analyses (FMEA, FRA), as well as contributing to the creation and review of the Validation Master Plan (VMP). You will also participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ, according to GMP/MDR requirements.

Your Profile
  • You hold an engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)
  • You have experience in process validation and equipment qualification in a GMP environment
  • You are fluent in German and English
  • You possess Swiss or EU citizenship


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    About the Role:We are looking for an experienced Process Validation Expert to join our team at agap2 Switzerland. The successful candidate will have a strong background in process engineering and excellent knowledge of Good Manufacturing Practices (GMP).Your primary responsibilities will include contributing to the integration of new production equipment and...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Commissioning & Qualification Engineer (C&Q)We are looking for an experienced Process Validation Engineer to join our team at agap2 Switzerland. As a Commissioning & Qualification Engineer (C&Q), you will support our clients in the realization of their projects on site by bringing your expertise and skills.Your main responsibilities include:Contributing to...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Commissioning & Qualification Engineer (C&Q)We are seeking a skilled Process Engineer to join our team at agap2 Switzerland. As a Consultant, you will be responsible for supporting our clients in the realization of their projects on site.Your key responsibilities:Integration of new production equipment and utilities in a biotech/pharma/medtech...


  • Bern, Bern, Schweiz Consulteer GmbH Vollzeit

    About this Role:The Process Definition Specialist will play a critical role in defining and refining processes to meet the evolving needs of our organization.Main Responsibilities:Define, document, and maintain detailed process documentation to ensure clarity and consistency.Work closely with stakeholders to understand requirements and develop solutions that...


  • Bern, Bern, Schweiz GXP CONSULTING Switzerland Vollzeit

    Job DescriptionWe are seeking a skilled Process Commissioning Specialist to support the startup of critical utilities and HVAC systems in a cutting-edge life sciences environment.This role involves commissioning, troubleshooting, and optimizing systems to ensure compliance with industry standards and operational efficiency.Commission and qualify black &...


  • Bern, Bern, Schweiz Agap2 - HIQ Consulting AG Vollzeit

    Company OverviewAgap2 - HIQ Consulting AG is a European engineering and operational consulting group founded in 2005, specializing in multiple industries including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.


  • Bern, Bern, Schweiz CSL Vollzeit

    The Computer System Validation Lead – Lab Execution Systems (LES), will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces.This role is part of a global function and can be based from our manufacturing sites in Melbourne, Australia or...


  • Bern, Bern, Schweiz Oxford Global Resources Vollzeit

    Job SummaryOxford Global Resources is seeking a skilled Biopharmaceutical Process Specialist to join our team. As a key member of our production team, you will be responsible for carrying out biopharmaceutical production activities in either upstream (USP) or downstream (DSP) processing.Perform daily manufacturing activities in USP or DSP, including...


  • Bern, Bern, Schweiz CSL Vollzeit

    Your Role The Computer System Validation Lead – Lab Execution Systems (LES), will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces. This role is part of a global function and can be based from our manufacturing sites in Melbourne,...


  • Bern, Bern, Schweiz Gi Group Vollzeit

    Gi Life Sciences, a leading partner in the pharmaceutical industry, is seeking a Process Improvement Specialist for its site in Canton Berne.Job Summary:The successful candidate will be responsible for defining and implementing process improvements, providing technical support to manufacturing operations, and enhancing manufacturing efficiency. This role...


  • Bern, Bern, Schweiz AMM Group Vollzeit

    About the RoleWe are seeking an experienced SAP EAM process specialist to join our team. As a key member of our project team, you will play a crucial role in delivering high-quality EAM solutions using S/4 HANA.Your primary responsibilities will include:Contributing to the standardization of EAM processes using S/4 HANA.Providing advisory services on...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Senior Process EngineerWe are seeking a senior Process Engineer to join our team at agap2 Switzerland. As a Consultant, you will be responsible for leading our clients' projects and ensuring smooth delivery.Your key responsibilities:Leadership of project teams in the integration of new production equipment and utilities in a biotech/pharma/medtech...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Commissioning & Qualification Engineer (C&Q)We are seeking a highly skilled Pharmaceutical Manufacturing Specialist to join our team at agap2 Switzerland. As a Commissioning & Qualification Engineer (C&Q), you will play a key role in supporting our clients in the realization of their projects on site.Your key responsibilities will include:Working closely...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Job Description:We are seeking a highly skilled Commissioning & Qualification Specialist to join our team at agap2 Switzerland. As a key member of our engineering services, you will be responsible for supporting clients in the realization of their projects on site.The ideal candidate will have experience in process validation and equipment qualification in a...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Company OverviewAgap2 Switzerland is a leading European engineering and operational consulting group specializing in various sectors including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Validation and Commissioning SpecialistWe are seeking a skilled Validation and Commissioning Specialist to join our team at agap2 Switzerland. As a Consultant, you will be responsible for ensuring that our clients' facilities meet regulatory requirements.Your key responsibilities:Integration of new production equipment and utilities in a...


  • Bern, Bern, Schweiz Recrutis Vollzeit

    Job DescriptionWe are seeking a highly experienced technical expert in upstream drug substance manufacturing operations and process sciences to lead projects with cross-functional teams at Recrutis.Role OverviewThe successful candidate will oversee all USP process transfer & sciences activities, leading cross-functional teams to facilitate new product...


  • Bern, Bern, Schweiz agap2 Switzerland Vollzeit

    Job RequirementsEngineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)Experience in process validation and equipment qualification in a GMP environmentGood Manufacturing PracticesFluent in German and EnglishSwiss or EU citizenshipAdditional InformationThe successful candidate will be part of a...

  • Electrical Engineer

    vor 2 Wochen


    Bern, Bern, Schweiz Darwin Recruitment Vollzeit

    We are looking for a skilled Process Automation Specialist to join our team. As a specialist in process automation, you will be responsible for the development, maintenance, and optimization of our process control systems.The ideal candidate will have:Hands-on experience with PCS7 standard and other control systems such as Modicon and CimplicityStrong...


  • Bern, Bern, Schweiz CSL Vollzeit

    Job Summary: The Automation Specialist Quality Control will be responsible for supporting the development and implementation of laboratory automation systems, creating documentation for qualification, validation, and lifecycle management, collaborating with internal and external stakeholders on technical requirement specifications, data integrity, and...