Process Engineer (GMP Manufacturing)

Astrix Inc.; Paris (KY); On-site; USD 62,000 - 74,000; Full time

Job summary

Astrix Inc. is seeking a hands-on Process Engineer to support manufacturing operations in a highly regulated cGMP environment. You will drive production performance, troubleshoot equipment and process issues, and support capital projects while advancing continuous improvement.

The role focuses on process optimization, yield improvement, and ensuring compliance with FDA, safety, and quality requirements in an onsite Paris, KY facility.

Qualifications

• Bachelor's Degree in Chemical Engineering or related field.
• 5+ years of Process Engineering experience in regulated manufacturing.
• Experience with cGMP, CAPA and process troubleshooting.

Responsibilities

• Provide engineering support for manufacturing operations and process performance.
• Investigate production issues and implement corrective actions (CAPA).
• Lead continuous improvement initiatives for process optimization and efficiency.
• Support capital projects involving equipment, facilities, and automation.
• Collaborate across Production, Quality, Safety, Maintenance and Engineering.

Skills

Analytical skills

Problem-solving

Communication

Education

Bachelor's Degree in Chemical Engineering

Tools

Excel

Word

PowerPoint

Job description

Pay Rate Low: 45 | Pay Rate High: 54

We are seeking a hands-on Process Engineer to support manufacturing operations within a highly regulated cGMP production environment. This role will focus on improving production performance, troubleshooting equipment and process issues, supporting capital projects, and driving continuous improvement initiatives.

Location: Paris, KY 40361

Pay: $45–$54/hr

Type: Contract-to-Hire

FullyOnsite

Key Responsibilities

• Provide engineering support for manufacturing operations, equipment reliability, and process performance.
• Investigate production issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Lead continuous improvement initiatives focused on process optimization, yield improvement, waste reduction, and operational efficiency.
• Support capital projects involving manufacturing equipment, facility upgrades, automation, and control systems.
• Partner with Production, Quality, Safety, Maintenance, and Engineering teams to resolve operational challenges.
• Develop and implement process performance metrics and monitoring tools.
• Support validation, change control (MOC), and process qualification activities.
• Work with vendors, contractors, and cross-functional stakeholders to implement process improvements.
• Analyze manufacturing data and recommend solutions to improve equipment uptime and product quality.
• Assist with new product introductions, technology transfers, and manufacturing scale-up activities.
• Ensure compliance with cGMP, FDA, safety, environmental, and quality requirements.

Qualifications

• Bachelor's Degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or a related Engineering discipline.
• 5+ years of Process Engineering experience within a pharmaceutical, chemical, biotechnology, or other regulated manufacturing environment.
• Experience supporting manufacturing operations, process improvements, and troubleshooting production issues.
• Knowledge of cGMP regulations and regulated manufacturing practices.
• Experience performing root cause investigations and implementing corrective actions.
• Strong analytical, problem-solving, and communication skills.
• Proficiency with Microsoft Excel, Word, and PowerPoint.

This jobdescription is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!