Process Engineer

Role Overview:

Seeking an experienced Process Engineer to support end-to-end manufacturing operations in an FDA-regulated biologics/aseptic environment, with strong focus on troubleshooting, process optimization, and validation support.

Key Responsibilities:

Provide hands-on engineering support across production processes and resolve equipment/process issues in real time with operations teams.

Lead investigations, root cause analysis, deviations, and corrective/preventive actions to improve process stability and performance.

Support validation activities including IQ/OQ/PQ, continued process verification (CPV), change control, and process monitoring.

Collaborate with QA, QC, Maintenance, and Operations to ensure robust, compliant, and efficient manufacturing processes.

Support line trials, startup/ramp-up activities, and process improvements focused on yield, quality, throughput, and waste reduction.

Assis...