Production Engineer (Solids & Liquids Manufacturing)

Stark Pharma Solutions Inc; Cleveland (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc. in Ohio is seeking a Production Engineer to support Solids and Liquids manufacturing operations. The role focuses on improving capacity, efficiency, and equipment reliability while leading troubleshooting and continuous improvement initiatives.

You will collaborate with Engineering, Maintenance, Quality, and Operations to enable successful product launches, address CAPA actions, and ensure cGMP compliance and safety in all activities.

Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• 3–8 years of Production, Process, Manufacturing, or Operations Engineering experience in pharma.
• Experience supporting Solids Manufacturing processes (tablet presses, encapsulators, coating, roller compaction, dry blending, CIP) or Liquids Manufacturing processes (homogenization, large-scale equipment, CIP).
• Strong knowledge of manufacturing processes, equipment troubleshooting, process optimization, and capacity improvement.
• Experience performing root cause analysis and implementing corrective and preventive actions.
• Experience with cross-functional teams in a regulated manufacturing environment.
• Knowledge of cGMP regulations and pharmaceutical manufacturing requirements.
• Strong problem-solving, communication, leadership, and project management skills.

Responsibilities

• Analyze equipment and process constraints to improve capacity, efficiency, yield, and overall manufacturing performance.
• Lead troubleshooting efforts and perform root cause analysis to resolve equipment and process-related issues.
• Analyze downtime data and implement corrective actions to improve reliability and reduce production interruptions.
• Drive continuous improvement initiatives through process optimization, best practice implementation, and operational excellence programs.
• Collaborate with Engineering, Maintenance, Quality, and Operations teams to support manufacturing objectives and resolve recurring issues.
• Support product launches and implementation of new manufacturing technologies.
• Provide technical leadership for equipment performance, process improvements, and manufacturing operations.
• Participate in investigations, CAPA activities, and operational excellence initiatives.
• Ensure compliance with cGMP, quality, and safety requirements.

Skills

Process optimization

Root cause analysis

CAPA implementation

Cross-functional collaboration

Project management

Communication skills

Leadership

Problem solving

Education

Bachelor's Degree in Engineering

Job description

Job Title: Production Engineer (Solids & Liquids Manufacturing)

Location: Ohio

Duration: Long Term

Position Overview

We are seeking an experienced Production Engineer to support pharmaceutical manufacturing operations within Solids and Liquids production environments. This role will focus on process optimization, equipment performance improvement, downtime reduction, continuous improvement initiatives, troubleshooting, and support for new product and technology implementations.

Key Responsibilities

• Analyze equipment and process constraints to improve capacity, efficiency, yield, and overall manufacturing performance.
• Lead troubleshooting efforts and perform root cause analysis to resolve equipment and process-related issues.
• Analyze downtime data and implement corrective actions to improve reliability and reduce production interruptions.
• Drive continuous improvement initiatives through process optimization, best practice implementation, and operational excellence programs.
• Collaborate with Engineering, Maintenance, Quality, and Operations teams to support manufacturing objectives and resolve recurring issues.
• Support product launches and implementation of new manufacturing technologies.
• Provide technical leadership for equipment performance, process improvements, and manufacturing operations.
• Participate in investigations, CAPA activities, and operational excellence initiatives.
• Ensure compliance with cGMP, quality, and safety requirements.

Required Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• 3 8+ years of Production, Process, Manufacturing, or Operations Engineering experience within the pharmaceutical industry.
• Experience supporting Solids Manufacturing processes, including tablet presses, encapsulators, coating systems, roller compaction, dry blending, drying operations, and CIP (Clean-in-Place) systems, or Liquids Manufacturing processes, including liquid processing operations, homogenization equipment, large-scale processing equipment, and CIP systems.
• Strong knowledge of manufacturing processes, equipment troubleshooting, process optimization, and capacity improvement initiatives.
• Experience performing root cause analysis and implementing corrective and preventive actions.
• Experience working with cross-functional teams in a regulated manufacturing environment.
• Knowledge of cGMP regulations and pharmaceutical manufacturing requirements.
• Strong problem-solving, communication, leadership, and project management skills.