Production Process Engineer

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

Job Title: Production Process Engineer

Location: Asheville, NC

Duration: Long Term

Position Overview

We are seeking an experienced Production Process Engineer to support manufacturing operations by optimizing production processes, improving operational efficiency, and ensuring product quality within a regulated pharmaceutical or medical device manufacturing environment. The ideal candidate will have experience in process optimization, manufacturing support, GMP compliance, data analysis, and cross-functional collaboration to drive continuous process improvements.

Key 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.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Manufacturing Engineering, or a related engineering discipline.
• Experience in pharmaceutical, biotechnology, or medical device manufacturing environments.
• Strong knowledge of production process optimization, manufacturing systems, and process improvement methodologies.
• Familiarity with GMP, FDA regulations, ISO standards, and regulated manufacturing practices.
• Experience analyzing manufacturing data, identifying process improvements, and implementing corrective actions.
• Knowledge of process validation, equipment qualification, and manufacturing documentation.
• Strong analytical, troubleshooting, problem-solving, and decision-making skills.
• Excellent communication, technical documentation, and cross-functional collaboration abilities.
• Experience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies is preferred.
• Familiarity with MES, ERP systems, statistical process control (SPC), and manufacturing KPIs is an added advantage.

LinkedIn: https://www.linkedin.com/company/99455976/