Production Process Engineer: GMP & Lean Optimizer

Stark Pharma Solutions Inc; Asheville (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc in Asheville, NC is seeking an experienced Production Process Engineer to optimize manufacturing processes, drive efficiency, and ensure product quality within a GMP-regulated environment.

You will analyze data, lead cross-functional teams, support validation and technology transfer, and contribute to Lean/Six Sigma initiatives to reduce waste. Excellent problem-solving and communication are essential.

Qualifications

• Bachelor's degree in Mechanical, Chemical, Industrial or Manufacturing Engineering.
• Experience in pharmaceutical, biotechnology, or medical device manufacturing environments.
• Knowledge of GMP, FDA regulations, ISO standards, and regulated manufacturing practices.
• Experience analyzing manufacturing data, identifying process improvements, and implementing corrective actions.
• Familiarity with MES, ERP systems, SPC, and manufacturing KPIs is an added advantage.

Responsibilities

• Optimize production and manufacturing processes to improve efficiency, productivity, and product quality.
• Monitor manufacturing process performance and identify opportunities for process improvements.
• Analyze production data, investigate process trends, and implement corrective and preventive actions.
• Ensure compliance with GMP, FDA regulations, ISO standards, and internal quality system requirements.
• Collaborate with Production, Manufacturing, Engineering, Quality Assurance, and Validation teams to support daily manufacturing operations.
• Troubleshoot production issues, perform root cause analysis, and implement sustainable process improvements.
• Develop and update process documentation, SOPs, work instructions, and manufacturing procedures.
• Support process validation, equipment qualification, and technology transfer activities.
• Participate in Lean Manufacturing, Six Sigma, and continuous improvement initiatives to reduce waste and improve operational performance.
• Assist with deviation investigations, CAPA implementation, change control, and regulatory audit readiness.

Skills

Process optimization

GMP compliance

Data analysis

Cross-functional collaboration

Lean Manufacturing

Six Sigma

Regulatory knowledge

Statistical Process Control

Education

Bachelor's degree in Mechanical, Chemical, Industrial or Manufacturing Engineering

Tools

MES

ERP systems

SPC

Job description

Stark Pharma Solutions Inc in Asheville, NC is seeking an experienced Production Process Engineer to optimize manufacturing processes, drive efficiency, and ensure product quality within a GMP-regulated environment.

You will analyze data, lead cross-functional teams, support validation and technology transfer, and contribute to Lean/Six Sigma initiatives to reduce waste. Excellent problem-solving and communication are essential.