Process Engineer - Manufacturing Deviations & CAPA

Our client seeks a Process Engineer to provide technical support to manufacturing process owners in a regulated pharmaceutical manufacturing environment. The successful candidate will provide technical input to deviation investigations and CAPA definition, including reviewing process data, batch records, and manufacturing process flows. Key Responsibilities Provide technical engineering support to manufacturing process owners during deviation investigations, including the review and interpretation of process data, batch records, and manufacturing process flows. Support root cause analysis and evaluate potential process impacts associated with manufacturing deviations and nonconformances. Collaborate with process owners and relevant stakeholders to define appropriate corrective and preventive actions (CAPAs) based on investigation findings. Support the planning, execution, documentation, and tracking of process-related CAPA actions through completion and closure. Identify and communicate required updates to standard operating procedures (SOPs), batch records, manufacturing instructions, and other controlled documents resulting from deviations and CAPAs. Provide technical input to ensure proposed corrective actions address identified process issues and support sustainable improvements. Collaborate with Manufacturing, Quality Assurance, and other relevant functions to facilitate effective resolution of process-related issues. Maintain accurate, complete, and timely documentation in accordance with applicable GMP requirements and site procedures. Qualifications and Requirements Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related engineering or scientific discipline. Experience in pharmaceutical, biopharmaceutical, or another regulated GMP manufacturing environment. Experience supporting manufacturing deviation investigations, root cause analysis, and CAPA development or implementation. Working knowledge of GMP requirements and pharmaceutical manufacturing documentation. Experience reviewing batch records, manufacturing process data, SOPs, and other controlled documentation. Strong analytical, problem-solving, organizational, and technical writing skills. Ability to collaborate effectively with process owners and cross-functional teams and manage assigned actions through completion. Preferred Qualifications Experience supporting process troubleshooting and manufacturing investigations in a pharmaceutical production environment. Familiarity with electronic quality management systems (eQMS) and deviation/CAPA tracking processes. Experience supporting continuous improvement initiatives and manufacturing process improvements. Experience in biologics, sterile manufacturing, or other specialized pharmaceutical manufacturing operations. #J-18808-Ljbffr