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
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