In this role, you will be an integral part of a team dedicated to managing and investigating deviations within a large-scale mammalian cell culture facility. Your primary focus will be to take ownership of deviations that arise, understand their root causes, assess their impact on products and systems, and formulate appropriate corrective and preventive actions (CAPAs). You will collaborate with various stakeholders to ensure compliance with industry standards while supporting ongoing process improvements.

Project Duration: Approx. 6 Months

Starting Date: ASAP

Key Responsibilities

  • Take ownership, author, and investigate deviations
  • Collaborate with Subject Matter Experts (SMEs) and key stakeholders to identify root causes and assess the potential impact of deviations
  • Utilize appropriate investigational tools to systematically determine root causes and contributing factors (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram)
  • Define suitable CAPAs and conduct associated effectiveness checks to rectify deviations and prevent future occurrences
  • Ensure compliance with current Good Manufacturing Practices (cGMP) throughout the investigation process, driving quality records to timely completion and closure
  • Support business initiatives through continuous change and process improvement activities

Candidate Profile

  • Bachelor’s degree in chemistry, biotechnology, life sciences, or a related field
  • Previous experience with deviations and cGMP in a regulated pharmaceutical/API setting is a significant advantage
  • Familiarity with biotech manufacturing processes and analytical methods is beneficial
  • Experience with Human and Organizational Performance and risk management approaches is a plus
  • Fluent in English, both written and spoken; proficiency in German is an advantage
  • Strong technical writing and communication skills, with demonstrated experience being a key asset
  • Highly organized, structured, and focused work ethic; open to new ideas and suggestions, with a motivation for agility and dynamic problem-solving
  • Ability to work collaboratively and lead a team of SMEs without formal authority, while also delivering projects independently

Job ID 41180394