In this role, you will take full ownership of deviation investigations within a large-scale mammalian cell culture environment. You will identify root causes, assess product and system impact, and implement sustainable corrective and preventive actions. Acting as a key interface between operations and quality stakeholders, you will ensure timely and compliant closure of deviation records.

Start Date: 02/03/2026

Duration: approx. 4 Months

Place of Work: Visp

Key Responsibilities

  • Take ownership of deviation records from initiation through investigation to final closure
  • Lead root cause investigations and document findings in compliance with internal quality standards
  • Partner with Subject Matter Experts and relevant stakeholders to evaluate deviation impact on products and systems
  • Apply structured investigational methodologies such as Fault Tree Analysis, Fishbone Diagram or Event and Causal Factor Analysis
  • Define appropriate CAPAs and effectiveness checks to ensure sustainable resolution and prevent recurrence
  • Maintain full compliance with cGMP requirements throughout the investigation lifecycle
  • Ensure accurate documentation and timely completion of quality records
  • Contribute to continuous improvement initiatives and support ongoing operational changes

Candidate Profile

  • Bachelor’s degree in Chemistry, Biotechnology, Life Sciences or a comparable discipline
  • Professional experience in deviation management within a regulated pharmaceutical or API manufacturing environment is highly desirable
  • Understanding of biotech manufacturing processes and related analytical techniques is advantageous
  • Knowledge of Human and Organizational Performance principles and risk-based approaches is beneficial
  • Fluent in English both written and spoken, German skills are a plus
  • Strong technical writing skills and the ability to clearly present complex information
  • Structured, detail-oriented and well-organized working style
  • Proactive mindset with adaptability and a high level of motivation

 

Job ID 18689