Senior Process Validation Engineer

Vor 3 Tagen

Biel, Bern, Schweiz B-Hive Switzerland Vollzeit

Joining B-HIVE Switzerland means…

Becoming part of a multi-specialized engineering company (life sciences, process industry, and manufacturing) that puts people and innovation at the heart of its projects.

In Switzerland, where quality of life and industrial excellence go hand in hand, we build with our employees an adventure based on:

  • Team spirit and collaboration
  • Trust and stability
  • Professional growth and fulfilment

Your project

As part of our growth, we are looking for
a Process Validation Engineer (Aseptic / Lyophilization)
to support one of our partners
in French-speaking Switzerland.

In this role, you will oversee end-to-end process validation activities in aseptic manufacturing, ensuring that processes, documentation, and compliance frameworks align with current GMP and regulatory expectations.

Your main responsibilities

  • Lead process validation and revalidation activities in aseptic manufacturing areas, including steps that may involve lyophilization.
  • Plan, author, review, and execute validation documentation such as risk assessments, protocols, reports, PPQ, cleaning validation, sterilization studies, and hold time studies.
  • Ensure that quality documentation and validation packages meet current standards and are properly structured.
  • Manage deviations, change controls, and CAPA with a structured and compliance-driven approach.
  • Support continuous improvement initiatives to enhance process robustness and operational efficiency.
  • Collaborate with production, quality, engineering, and technical teams to ensure validated processes remain compliant and consistent.
  • Contribute to regulatory or client audits related to aseptic operations and process validation activities.

Your profile

  • Degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related field.
  • Proven experience in process validation or CQV within aseptic manufacturing.
  • Solid understanding of GMP/ICH guidelines and data integrity principles.
  • Experience managing multi-batch validation activities.
  • Strong technical writing, analytical thinking, and stakeholder communication skills.
  • Ability to work autonomously in a fast-paced, regulated environment.
  • Fluent in French and English

Only candidates who are Swiss nationals, EU/EFTA citizens, or hold a valid Swiss work and residence permit will be considered.

Why join B-HIVE Switzerland?

  • A close-knit and ambitious team, where each member plays a key role in our collective success.
  • A multi-specialized engineering hub offering varied projects and recognized expertise.
  • A stimulating and supportive environment with training opportunities and long-term career development.
  • The chance to thrive in Switzerland, where innovation, work-life balance, and international vision come together.

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