Senior Process Engineer

Aegis Worldwide; Indianapolis (IN); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Day 1 medical

Dental

Vision

401(k)

PTO

Job summary

Aegis Worldwide is partnered with a growing pharmaceutical manufacturer in the Indianapolis area that is looking to add a Senior Process Engineer to its team. This is a direct-hire opportunity supporting a highly regulated manufacturing operation with excellent long-term growth potential.

You will lead process improvement initiatives, troubleshoot processes and equipment, and drive CAPAs and change controls while ensuring compliance with cGMP and quality standards.

Qualifications

• Bachelor's degree in Engineering required (Mechanical preferred)
• 5+ years of engineering experience in regulated manufacturing environments
• Experience with process optimization, troubleshooting, equipment reliability, and continuous improvement
• Experience with root cause analysis, CAPAs, change controls, and engineering documentation
• Knowledge of cGMP manufacturing and regulated environments
• Lean Manufacturing and/or Six Sigma experience is a plus

Responsibilities

• Lead process improvement initiatives to improve manufacturing efficiency, reliability, and product quality.
• Troubleshoot manufacturing processes and equipment to resolve production issues.
• Lead root cause investigations and implement CAPAs.
• Write and maintain engineering documentation including change controls, technical reports, and process documentation.
• Support new product introductions, manufacturing line improvements, and equipment implementation projects.
• Partner with Manufacturing, Quality, Validation, R&D, and Engineering teams to drive continuous improvement.
• Ensure manufacturing processes remain compliant with cGMP and quality standards.

Skills

Root cause analysis

CAPAs

Change controls

Process optimization

Lean/Six Sigma

Education

Bachelor's degree in Engineering

Job description

Compensation: $100,000-$110,000 base salary + bonus

Benefits: Day 1 medical, dental, vision, 401(k), PTO, and more

Aegis Worldwide is partnered with a growing pharmaceutical manufacturer in the Indianapolis area that is looking to add a Senior Process Engineer to its team. This is a direct-hire opportunity supporting a highly regulated manufacturing operation with excellent long-term growth potential.

What You'll Do

• Lead process improvement initiatives to improve manufacturing efficiency, reliability, and product quality.
• Troubleshoot manufacturing processes and equipment to resolve production issues.
• Lead root cause investigations and implement corrective and preventive actions (CAPAs).
• Write and maintain engineering documentation including change controls, technical reports, and process documentation.
• Support new product introductions, manufacturing line improvements, and equipment implementation projects.
• Partner with Manufacturing, Quality, Validation, R&D, and Engineering teams to drive continuous improvement.
• Ensure manufacturing processes remain compliant with cGMP and quality standards.

What We're Looking For

• Bachelor's degree in Engineering (Mechanical preferred, but other engineering disciplines will be considered).
• 5+ years of engineering experience in pharmaceutical, biologics, medical device, food, or another highly regulated manufacturing environment.
• Experience with manufacturing process optimization, troubleshooting, equipment reliability, and continuous improvement.
• Experience with root cause analysis, CAPAs, change controls, and engineering documentation.
• Knowledge of cGMP manufacturing and regulated environments.
• Lean Manufacturing and/or Six Sigma experience is a plus.