Process Engineer

Intellectt Inc; Omaha (NE); On-site; USD 85,000 - 120,000; Full time

Job summary

Intellectt Inc is seeking an experienced Process Engineer to support manufacturing operations in an FDA-regulated biologics and aseptic environment. The role involves troubleshooting, process optimization, and validation support while collaborating with operations teams to resolve issues in real time.

The ideal candidate will have 7–10+ years of experience and a strong background in biologics processing. A Bachelor’s degree in engineering is required, along with familiarity with Lean, TPM, and other engineering methodologies.

Qualifications

• 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.

Responsibilities

• Provide hands-on engineering support across production processes and resolve equipment/process issues.
• Lead investigations, root cause analysis, deviations, and corrective/preventive actions.
• Support validation activities including IQ/OQ/PQ and continued process verification.
• Collaborate with QA, QC, Maintenance, and Operations for compliance and efficiency.
• Assist Project Engineering from URS development through FAT/SAT and installation.

Skills

Process optimization

Troubleshooting

Root cause analysis

Validation support

FDA-regulated environments

Education

Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering

Tools

SAP

MES

Power BI

Job description

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.