Process Engineer

Actalent; Tennessee; On-site; USD 70,000 - 100,000; Full time

Job summary

Actalent is seeking a Process Engineer to improve manufacturing efficiency in a pharmaceutical packaging environment in Clinton, TN. The role focuses on optimizing production processes, supporting process validation, and driving continuous improvement initiatives.

You will analyze data, troubleshoot issues, and collaborate with Operations, Quality, Maintenance, and Engineering to enhance OEE, throughput, and product quality. This is a contract-to-hire position based in Clinton, TN.

Qualifications

• 1 year of experience in a cGMP manufacturing environment.
• Strong knowledge of FDA-regulated manufacturing practices.
• Bachelor's degree in Engineering.
• 4+ years of engineering experience, preferably in manufacturing.
• Experience with process optimization and troubleshooting.
• Proficiency in Excel for data analysis and reporting.
• Experience with Lean and Six Sigma concepts.
• Knowledge of KPI development and performance tracking.

Responsibilities

• Analyze existing manufacturing processes to improve efficiency, quality and throughput.
• Conduct production trials and machine testing to validate changes.
• Troubleshoot line performance and implement corrective actions.
• Optimize machine settings to boost OEE and reduce waste.
• Develop reports and dashboards with Excel and Power BI.
• Lead Lean continuous improvement initiatives.

Skills

cGMP experience

FDA compliance

Data analysis with Excel

OEE analysis

Lean manufacturing

Six Sigma knowledge

Root cause analysis

Process optimization

Education

Bachelor's degree in Engineering

Tools

MES (Manufacturing Execution Systems)

Automation systems

Job description

Job Description

Job Description

Job Title: Process Engineer

Job Description

This Process Engineer role focuses on improving manufacturing efficiency, optimizing production processes, and supporting process validation activities within a pharmaceutical packaging environment. You will analyze production data, troubleshoot manufacturing issues, and collaborate closely with operations and cross-functional teams to enhance overall equipment effectiveness (OEE), throughput, and product quality while driving continuous improvement initiatives.

Responsibilities

• Analyze existing manufacturing processes and identify opportunities to improve efficiency, quality, and throughput.
• Conduct production trials and machine testing to validate process changes and optimize performance.
• Troubleshoot production line performance issues and implement effective corrective actions.
• Optimize machine settings and process parameters to enhance OEE, reduce waste, and improve consistency.
• Track and monitor key performance metrics, including OEE, downtime, waste, and productivity.
• Develop, maintain, and present reports and dashboards using tools such as Excel and Power BI to support data-driven decision-making.
• Lead Lean and continuous improvement initiatives to standardize processes and eliminate inefficiencies.
• Create and maintain technical documentation, work standards, and process instructions.
• Support the implementation and qualification of new equipment and manufacturing processes.
• Work cross-functionally with Operations, Quality, Maintenance, and Engineering teams to resolve issues and implement improvements.
• Apply root cause analysis methodologies to investigate process deviations, performance issues, and quality concerns.
• Contribute to process validation activities to ensure manufacturing processes meet regulatory and quality requirements.

Essential Skills

• Minimum 1 year of experience working in a cGMP manufacturing environment.
• Strong understanding of FDA-regulated manufacturing practices and pharmaceutical quality requirements.
• Bachelor's degree in Engineering.
• At least 4 years of engineering experience, with a preference for manufacturing or process engineering.
• Demonstrated experience in process optimization and process improvement within a manufacturing setting.
• Hands-on experience with root cause analysis and production troubleshooting.
• Experience improving manufacturing workflows and standardizing processes.
• Proficiency in OEE analysis, downtime tracking, and waste reduction initiatives.
• Strong Excel skills, including the ability to analyze data and create reports.
• Proven ability to use data and performance metrics to drive decisions and improvements.
• Experience with Lean manufacturing principles and continuous improvement methodologies.
• Familiarity with Six Sigma concepts and KPI development and tracking.
• Experience in manufacturing engineering, process engineering, or a closely related discipline.

Additional Skills & Qualifications

• Sterile manufacturing experience.
• Experience in pharmaceutical packaging operations.
• Experience with MES (Manufacturing Execution Systems).
• Process validation experience in a regulated manufacturing environment.
• Knowledge of automation and manufacturing systems.
• Statistical analysis experience to support process and quality improvements.
• Experience with medical device or medical manufacturing environments.
• Formal training or demonstrated experience in continuous improvement and Lean manufacturing.

Work Environment

The role is based in a medical and pharmaceutical manufacturing environment with a strong focus on cGMP compliance and FDA-regulated processes. You will work closely with operations, quality, maintenance, and engineering teams on the production floor and in an office setting to analyze data, monitor performance metrics, and implement process improvements. The environment emphasizes continuous improvement, collaboration, and adherence to documented work standards and technical procedures. You can expect to work with technologies such as pharmaceutical packaging equipment, automation and manufacturing systems, Excel-based reporting tools, and business intelligence tools like Power BI. The workplace culture supports professional growth within a growing team and encourages active participation in Lean and continuous improvement initiatives. Specific work hours and shift details may vary based on production needs.

Job Type & Location

This is a Contract to Hire position based out of Clinton, TN.