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About Bacthera

Bacthera is a leading Contract Development and Manufacturing Organization (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. Our global presence includes headquarters in Basel and production facilities in Spain, Denmark, and Switzerland. We bring together best-in-class, complementary capabilities and are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

Job Summary

We are seeking a highly skilled Computer System Validation (CSV) Engineer to join our team. As a CSV Engineer, you will be responsible for ensuring that Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health authorities.

Key Responsibilities

  • Developing CSV Policies and SOPs aligned with applicable regulatory expectations and industry standards
  • Developing protocols for CSV in accordance with policy and procedures
  • Leading assigned CSV for the process equipment of 4 facilities and providing guidance to local teams
  • Liaising with stakeholders to ensure accurate and timely completion of CSV tasks
  • Reviewing and analyzing related Deviations, CAPAs, and Changes

Requirements

  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or related field
  • A minimum of 5 years of experience in CSV, MES, SCADA, and OT systems
  • Good understanding of manufacturing processes and related process equipment
  • Extensive experience in a regulated pharmaceutical environment and GMP requirements
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment

What We Offer

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package