Manufacturing Project Engineer

My client is a leading biopharmaceutical manufacturer with a state-of-the-art, multi-product biologics facility. They are seeking a Manufacturing Projects Scientist/Engineer to support new product introductions and process improvement initiatives within a dynamic GMP manufacturing environment. Key Responsibilities: Collaborate with cross-functional teams (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain) to implement process improvements, new product start-ups, and process changes. Support risk assessments, process technology transfer, and the creation of manufacturing documentation for development and PPQ batches. Lead or support product changeovers, impact assessments, and investigations. Provide subject matter expertise on new manufacturing processes and documentation.

Support the introduction of new raw materials, consumables, and technologies (e. g. , single-use systems). Own and drive change controls, CAPAs, improvement projects, and safety initiatives. Provide training and knowledge transfer to operational teams. Support internal and external audits and contribute to a culture of Right-First-Time execution. Collaborate with sustaining teams to ensure smooth transitions between products and minimal disruption to existing operations. Ideal Candidate Profile: Degree (Bachelor's or Master’s) in Science, Engineering, or related field. Proven experience in GMP biologics manufacturing, with strong knowledge of cell culture processes and equipment.

Experience in new product introductions, technology transfer, and cross-functional collaboration. Strong problem-solving, project management, and lean manufacturing expertise. Familiarity with DeltaV, MES Syncade, and SAP is highly desirable. Excellent communication, leadership, and stakeholder management skills. Demonstrated ability to close out complex technical investigations and support audit readiness. The Next Step for you: Should this position be of interest to you please submit your CV to Barry O’Mahony from Next Generation Recruitment using the apply button. Next Generation will never share your data outside of our organisation without your prior written consent.

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