Process Engineer Description: The Process Engineer will support the pre-filled syringe processes within a sterile manufacturing environment, focusing on continuous improvement, technology transfer, and capacity enablers for monoclonal antibody (mAb) commercial products.
Responsibilities: Act as Process Engineer for projects related to pre-filled syringe operations.Develop and execute filter tests, fill weight cycles, and cleaning verification activities.Generate and execute documentation such as recipe documents, FMEAs, protocols, and reports.Lead investigations and manage change controls to resolve technical issues.Ensure activities are delivered on schedule and within budget.Support daily operations in the syringe filling area and implement corrective actions for continuous improvement.Collaborate with material/component vendors during projects.Write Process/Operational Control Strategy documents and support operator training.Create hour-by-hour schedules for planning line time and execution of deliverables.Provide technical support to implement process improvements and new product transfers.Participate in GMP regulatory and safety audits.Requirements: Honours degree in an Engineering discipline.3+ years of relevant experience in a highly regulated GMP environment.Experience in sterile manufacturing operations is an advantage.Experience with syringe filling processes is a distinct advantage.Experience in new product introduction is preferred.Strong problem-solving skills.
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