Process Engineer

4 weken geleden


Leiden, Nederland Panda International Voltijd

Job Role: DSP Process EngineerAbout the Role:We are seeking a DSP Process Engineer with strong experience in downstream operations. You will act as the subject matter expert (SME) for purification processes and DSP equipment, supporting daily operations, leading process improvements, and managing activities for New Product Introduction (NPI) and technology transfer. This role requires hands-on operational experience, solid GMP knowledge, and strong documentation skills.Key Responsibilities:Serve as the DSP SME for downstream operations.Support and optimize purification processes and large-scale DSP equipment.Lead and support NPI and technology transfer activities.Manage deviations, non-conformities, and change controls in electronic quality systems.Ensure DSP processes comply with GMP and regulatory expectations.Prepare and review documentation, including SOPs, batch records, and regulatory files.Identify and drive process improvements to increase reliability, efficiency, and yield.Work closely with cross-functional teams such as upstream operations, engineering, quality, and logistics.Provide scientific justification and clear documentation for process decisions.Must Requirements:5–8 years of experience in pharmaceutical or biopharmaceutical manufacturing.Strong operational background in Downstream Processing (DSP).Experience with NPI and technology transfer.Solid knowledge of GMP, deviation handling, and process optimization.Experience with systems like COMET, Veeva, or TrackWise.MSc in Life Sciences, Biotechnology, or a related field.Experience with mAbs, biosimilars, bispecifics, or vaccines.Strong documentation and writing experience.Practical’s:Location: Leiden, the NetherlandsDuration: 12 months + extensionStart Date: ASAPWork Model: Full-time, HybridInterested or know someone who might be? Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.


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