Deviation Specialist – Large-Scale Mammalian Cell Culture Facility | Global Role
Job Description
A leading pharmaceutical manufacturing is seeking a highly skilled Deviation Specialist to take ownership of deviations within a large-scale mammalian cell culture facility. In this role, you will represent the Operations Unit, investigating root causes, evaluating impacts on product and systems, and defining appropriate CAPA(s) to prevent recurrence. The position requires strong expertise in deviation management, cGMP compliance, and cross-functional collaboration with Subject Matter Experts and key stakeholders.
You will contribute to continuous process improvement initiatives and ensure all deviation investigations are completed accurately and in a timely manner, maintaining high-quality records and compliance standards.
* Bachelor’s degree in Chemistry, Biotechnology, Life Science, or related field
* Proven experience managing deviations within cGMP-regulated pharmaceutical or API manufacturing environments
* Strong understanding of biotech manufacturing processes and analytical methods (preferred)
* Knowledge of Human and Organizational Performance & risk management approaches (advantageous)
* Fluency in English, both written and spoken; German is an advantage
* Excellent technical writing, presentation, and communication skills
* Structured, focused, and highly organized working style
* Agile, motivated, and dynamically driven with openness to new ideas
Preferred Requirements
* Experience with systematic investigation tools (Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.)
* Previous track record in defining and implementing effective CAPA(s)
* Experience supporting ongoing change and process improvement activities
* Ability to work collaboratively across departments and with multiple stakeholders
Practicalities
Start Date: ASAP
Leadership: Reports to Operations/Quality leadership
Scope: Deviation ownership and investigation across a large-scale mammalian cell culture facility
Interested?
Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.
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