Senior Process Engineer at Aegis Worldwide Senior Process Engineer at Aegis Worldwide in Noblesville, Indiana Posted in 16 days ago.

Type:

full-time 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 Lean/Six Sigma experience preferred Up to 10% travel

Benefits:

$105K-$110K base + 5% bonus Direct-hire position Benefits begin Day 1 Medical, dental, and vision 401(k) PTO, including 20 days in the first full year 4 floating holidays + 9 paid holidays Monday-Friday, 8:00 AM-5:00 PM