About Our Client
Our client is a global biotechnology company at the forefront of cell therapy, developing innovative treatments that are transforming the way cancer is treated. Their state-of-the-art manufacturing facility in Hoofddorp combines science, engineering, and advanced manufacturing to produce life-changing therapies in a highly regulated GMP environment. Employees have the opportunity to work alongside multidisciplinary teams while contributing directly to products that make a real difference for patients worldwide.
About the Position
As a Process Engineer, you will join the Manufacturing Operations & Compliance Support (MOCS) team within MSAT, where you'll provide technical support to commercial manufacturing. You'll play a key role in ensuring manufacturing processes remain robust, compliant, and efficient by investigating process deviations, supporting product release activities, driving continuous improvements, and implementing sustainable solutions. This is a highly collaborative position where you'll work closely with Manufacturing, Quality, Validation, and Engineering teams.
Key Responsibilities
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Perform technical assessments to support manufacturing and product release
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Lead investigations into process deviations and identify root causes
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Develop and implement effective CAPAs to prevent recurrence
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Support process optimization and continuous improvement projects
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Prepare and revise technical documentation, including SOPs and batch records
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Collaborate with cross-functional teams to resolve technical and operational challenges
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Ensure manufacturing activities remain compliant with cGMP requirements
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Contribute to change controls and process improvement initiatives
Requirements
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Bachelor's degree in Biotechnology, Chemical Engineering, Biochemical Engineering, or a related scientific discipline
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Experience within cell therapy, cell culture, aseptic processing, or biopharmaceutical manufacturing
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Strong knowledge of cGMP manufacturing and compliance
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Experience with deviation investigations, Root Cause Analysis, CAPAs, and change controls
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Strong analytical and problem-solving skills
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Comfortable working in a dynamic, fast-paced manufacturing environment
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Excellent communication skills with the ability to collaborate across multiple departments
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Self-motivated, detail-oriented, and proactive in driving technical improvements
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Emmanouil Spinthakis
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