Process Engineer – Cell & Gene Therapy

Key Responsibilities

• Lead equipment implementation from design through commissioning, qualification, and validation.
• Support automation projects, process optimization, and manufacturing system improvements.
• Execute FAT, SAT, commissioning, and startup activities.
• Troubleshoot process and equipment issues to improve manufacturing performance.
• Support technology transfer, CAPAs, change controls, and deviation investigations.
• Collaborate with Manufacturing, MSAT, Validation, Quality, and Engineering teams to ensure successful project execution.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field.
• Experience in Cell & Gene Therapy, Biopharmaceutical, or Pharmaceutical Manufacturing.
• Hands-on experience with process engineering, equipment implementation, and GMP manufacturing.
• Knowledge of commissioning, qualification, validation, FAT/SAT, and technology transfer activities.
• Experience with automation systems and continuous process improvement.
• Strong troubleshooting, communication, and cross-functional collaboration skills.

Pay

$100,000 - $120,000 annually

Schedule

Full-time, 40 hours per week

Benefits

Health insurance, retirement plan, paid time off