Process Engineer

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. Assist Project Engineering from URS development through FAT/SAT and installation/qualification activities. Required Experience & Skills: 7–10+ years of process engineering experience in FDA-regulated or controlled manufacturing environments. Strong expertise in biologics/aseptic processing and troubleshooting in live production settings. Hands-on experience with deviations, investigations, RCA, change control, and process improvement. Working knowledge of validation lifecycle and project engineering principles. Ability to work full-time on-site in a manufacturing environment with direct operator interaction. Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering discipline. Preferred Experience: Exposure to startup, tech transfer, or new product introduction. Familiarity with Lean, TPM, FMEA, CPV, and reliability improvement methodologies. Experience with SAP, MES, or Power BI systems. #J-18808-Ljbffr