Senior Process Engineer

Aegis Worldwide; Noblesville (IN); On-site; USD 105,000 - 110,000; Full time

Benefits offered by this job

Day 1 benefits

Medical/Dental/Vision

401(k)

PTO 20 days

Job summary

Aegis Worldwide is seeking a Senior Process Engineer for sterile pharmaceutical manufacturing in Noblesville, IN. The role focuses on process optimization, equipment reliability, troubleshooting, and implementing new products and processes within a cGMP environment.

You will lead process improvements, CAPAs, change controls, and support for product launches and process transfers, with up to 10% travel. Benefits begin Day 1, with medical, dental, vision, and 401(k) plans.

Qualifications

• Bachelor’s degree in Engineering (Mechanical preferred).
• 5+ years of engineering experience in regulated manufacturing (pharmaceutical, biologics, medical device, food, or similar).
• 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.

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.

Skills

Root cause analysis

Process improvement

CAPA management

Cross-functional collaboration

Education

Engineering degree (Mechanical preferred)

Job description

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