Process Engineer - Manufacturing Deviations & CAPA

Position Overview

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.