Senior Process Engineer

Senior Process Engineer | Noblesville, IN | $105K–$110K + 5% Bonus

A leading highly regulated manufacturing organization is hiring a Senior Process Engineer to support sterile pharmaceutical manufacturing in Noblesville, IN. This role will focus on process optimization, equipment reliability, troubleshooting, and new product/process implementation within a highly regulated cGMP environment.

Responsibilities:

• Lead process improvement, reliability, and troubleshooting initiatives
• Investigate root causes and implement CAPAs and corrective actions
• Develop change controls, technical documentation, protocols, and reports
• Support new product launches, process transfers, and new manufacturing equipment
• Partner cross-functionally with Manufacturing, Quality, R&D, Validation, and Project Management
• Establish and improve process KPIs and manufacturing efficiency

Requirements:

• Bachelor’s degree in Engineering; Mechanical preferred
• 5+ years of engineering experience in pharmaceutical, biologics, medical device, food, or other highly regulated manufacturing
• Experience with cGMPs, validation, quality systems, and document control
• Strong root cause analysis and process improvement experience
• Experience with CAPAs, deviations, change controls, and technical documentation
• Pharmaceutical packaging, automated inspection, or vial labeling experience is a plus
• Up to 10% travel
• $105K–$110K base + 5% bonus
• Benefits begin Day 1
• Medical, dental, and vision
• 401(k)
• PTO, including 20 days in the first full year