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.

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.