Job Description

Description:

The Process Engineer supports the compliant, efficient, and safe operation and technology transfer of sterile manufacturing processes from development through commercial scale. The role executes process and cleaning validation activities, analyzes manufacturing data, assists with scale‑up and aseptic process simulations, and contributes to troubleshooting and continuous improvement. Working with Manufacturing, Quality, Validation, Engineering, R&D, and vendors, the engineer supports formulation, filling, packaging, lyophilization, dehydrogenation, sterilization, and contamination‑control processes under appropriate technical guidance.

Essential Functions:

• Authors and executes protocols and reports in accordance with FDA, cGMP, and site requirements for process validation, cleaning validation, and assigned equipment or automation qualification activities. Monitors and analyzes manufacturing data to support continued process verification, process lifecycle management, investigations, deviations, and resolution of process anomalies.
• Supports technical plans, process assessments, project scopes, risk assessments, and schedules for establishing manufacturing capability and introducing new or reformulated products. Coordinates with R&D, Manufacturing, Quality, and Validation to support technology transfer, scale-up, aseptic process simulations, and process performance qualification. Assists with feasibility evaluations and implementation of technologies that improve manufacturing capability.
• Provides day-to-day technical support and troubleshooting for manufacturing processes and equipment. Supports start-up of new processes or equipment, prepares manufacturing instructions, and trains operations personnel. Evaluates quality, yield, throughput, cycle time, process parameters, cGMP compliance, safety, and environmental requirements. Collaborates with vendors and technical specialists to review requirements and functional specifications for filling, sterilization, decontamination, and environmental-control systems.
• Supports chemical and biological formulation, filling, packaging, lyophilization, depyrogenation, and contamination-control operations. Drafts and revises SOPs, process instructions, and batch records. Initiates or supports change controls and impact assessments; participates in investigations, root-cause analysis, data review, and CAPA implementation; and maintains accurate process knowledge and lifecycle documentation.

Additional Responsibilities:

• Reviews and updates P&IDs, process flow diagrams, equipment layouts, engineering drawings, and process engineering documents.Occasional international and national travel is required for new projects. Applies project management principles to track assigned timelines, actions, and risks and to communicate effectively with cross-functional teams.