The Life Science Career Network – CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.

Laboratory Systems Analyst – 6091

We are looking for a Laboratory Systems Analyst with GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities for a 12-month contract (with a high possibility of an extension for another year) in Bern.

In this role, you will collaborate with relevant stakeholders to ensure laboratory are compliant with Data Integrity guidelines by implementing a Data Audit Trail Review process. With your proactive and self-responsible approach, you take decisions and drive progress forward.

Main Responsibilities:

  • Assess laboratory instruments and software for their compliance with Data Integrity guidelines.
  • Implement Data Audit Trail Reviews for laboratory instruments and software in accordance with guidelines.
  • Create documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with Engineering and I&T departments
  • Manage local and global qualification and validation projects.
  • Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity, and automation activities.
  • Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
  • 3+ years’ experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities.
  • First project management experience in an operational environment.
  • Knowledge of regulations on computerized systems and laboratory automation, and a willingness to extend skills and know-how in the field.
  • Strong written and verbal communication skills in German and English, both oral and written, to ensure effective collaboration with cross-functional teams both locally and globally across all CSL sites.
  • Strong analytical/problem-solving skills, technical IT affinity, and organizational skills.
  • Ability to work independently and as a team member in a high-performance environment.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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