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.
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.
