Senior Biologics Process Engineer - On-Site & Validation

Intellectt Inc; Omaha (NE); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Process optimization

Troubleshooting

Root cause analysis

Validation support

FDA-regulated environments

Formation

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

Outils

SAP

MES

Power BI

Description du poste

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.