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CSV Engineer.

dettagli di lavoro

dettagli offerta.

  • categoria
    engineering
  • Contatto
    Sandra Roleira
  • riferimento
    19780

velocizza la candidatura condividendo il tuo profilo

dettagli di lavoro

Temporary contract - 12 months 
Start date : 03.01.2024
End date : 31.12.2024

Do you have a background in technical or natural sciences with experience in pharma or biotech industries? Are you a committed professional who can thrive in a fast-changing environment, and who is ready to make a significant impact?

This role is for you!

Role and Responsibilities

As a Computer System Validation Engineer, you will be entrusted with key responsibilities within our Technical Services department. Based in Bern, with a minimum of 3 days on-site presence per week, your tasks will include:
 

  • Leading the CSV package(s) on assigned projects, maintaining accountability for work produced by yourself and colleagues.
  • Planning, coordinating, and executing all phases of computer system validation for production and QC Lab systems.
  • Conducting CSV periodic review of equipment and systems.
  • Preparing, reviewing, and approving technical and GMP related documentation.
  • Coordinating and executing FAT/SAT, commissioning activities focused on CSV for new systems.
  • Managing operational handling of Change Controls, CAPAs and Non-Conformances related to CSV.
 Requirements

To succeed in this role, you will need:

  • A bachelor's or master's degree in technical or natural sciences.
  • Minimum of 3 years of working experience within pharma or a biotech company.
  • Experience validating computerized manufacturing equipment and software & hardware infrastructure.
  • A minimum of 4 years of working experience with CSV.
  • Excellent communication skills and an analytical mindset.
  • Business fluency in English.


Preferred but not essential:

  • Proficiency in German.
  • Experience validating complex computerized analytical equipment (QC Laboratory equipment).
  • Basic knowledge of Validation requirements according to cGMP regulations.
  • Basic understanding of quality assurance principles.
 Next Steps

If you're ready to take the next step in your career, we invite you to apply. The recruitment process will involve an initial screening, followed by interviews. Our dedicated recruiting team is ready to guide you through each step and answer any questions you may have. We look forward to receiving your application.

Temporary contract - 12 months 
Start date : 03.01.2024
End date : 31.12.2024

Do you have a background in technical or natural sciences with experience in pharma or biotech industries? Are you a committed professional who can thrive in a fast-changing environment, and who is ready to make a significant impact?

This role is for you!

Role and Responsibilities

As a Computer System Validation Engineer, you will be entrusted with key responsibilities within our Technical Services department. Based in Bern, with a minimum of 3 days on-site presence per week, your tasks will include:
 

  • Leading the CSV package(s) on assigned projects, maintaining accountability for work produced by yourself and colleagues.
  • Planning, coordinating, and executing all phases of computer system validation for production and QC Lab systems.
  • Conducting CSV periodic review of equipment and systems.
  • Preparing, reviewing, and approving technical and GMP related documentation.
  • Coordinating and executing FAT/SAT, commissioning activities focused on CSV for new systems.
  • Managing operational handling of Change Controls, CAPAs and Non-Conformances related to CSV.
 Requirements

To succeed in this role, you will need:

  • A bachelor's or master's degree in technical or natural sciences.
  • Minimum of 3 years of working experience within pharma or a biotech company.
  • Experience validating computerized manufacturing equipment and software & hardware infrastructure.
  • A minimum of 4 years of working experience with CSV.
  • Excellent communication skills and an analytical mindset.
  • Business fluency in English.


Preferred but not essential:

  • Proficiency in German.
  • Experience validating complex computerized analytical equipment (QC Laboratory equipment).
  • Basic knowledge of Validation requirements according to cGMP regulations.
  • Basic understanding of quality assurance principles.
 Next Steps

If you're ready to take the next step in your career, we invite you to apply. The recruitment process will involve an initial screening, followed by interviews. Our dedicated recruiting team is ready to guide you through each step and answer any questions you may have. We look forward to receiving your application.

contattaci.

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

SR

Sandra Roleira

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