Process Engineer (Process Development Engineer)

TalentBurst, an Inc 5000 company; Tucson (AZ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading manufacturing firm in Tucson, AZ is seeking a Process Engineer to focus on process development and continuous improvement within manufacturing operations. This onsite position requires a Bachelor's degree in Engineering or a related field along with 2-5 years of experience. Responsibilities include designing processes, leading Lean initiatives, and ensuring compliance with Good Manufacturing Practices (GMP). Exceptional analytical and teamwork skills are essential for success in this role.

Qualifications

• 2-5 years of relevant work experience in process engineering.
• Basic knowledge of GMP and regulatory standards.
• Preferred knowledge of Lean and Six Sigma methodologies.

Responsibilities

• Design and improve manufacturing processes aiming for reduced cycle time.
• Lead Lean Manufacturing initiatives to enhance efficiency.
• Ensure compliance with cGMP and internal quality standards.

Skills

Analytical skills

Problem-solving skills

Teamwork abilities

Lean principles knowledge

Six Sigma methodologies

Education

Bachelor's Degree in Engineering or Life Science

Tools

Process simulation software

Minitab

Job description

Process Engineer (Process Development Engineer)

Tucson, AZ

24 Months

***This is an onsite position for a Process Engineer in the Manufacturing Operations department.

Required Education & Experience

• Bachelor's Degree (required), preferably in Engineering/Engineering Technology or a Life Science discipline.
• 2-5 years of relevant work experience.
• Basic knowledge of GMP and regulatory standards.
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Knowledge of Lean principles and/or Six Sigma methodologies (preferred).

The Opportunity

Focus on continuous improvement, design, automation, cGMP compliance, and quality management within manufacturing processes.

Lead Lean Manufacturing initiatives to enhance efficiency and effectiveness.

Key Responsibilities

Process Engineering & Improvement (60%)

• Design, develop, and improve manufacturing processes for new and existing products (aiming for reduced cycle time).
• Analyze process data and perform troubleshooting to resolve technical issues and decrease downtime.
• Design and implement automation solutions to streamline processes.
• Support process validation and qualification activities.
• Utilize process simulation software and engineering tools for optimization.
• Manage project timelines for equipment repairs, maintenance, and upgrades.

Compliance & Quality (10%)

• Ensure strict adherence to current Good Manufacturing Practices (cGMP) and internal quality standards.
• Maintain documentation (flow diagrams, work instructions, reports).
• Conduct risk assessments and develop mitigation strategies.
• Assist in audit readiness and Non-Conformance Report (Client) investigations.
• Identify and escalation potential safety hazards.

Continuous Improvement (30%)

• Apply Lean principles to eliminate inefficiencies and waste.
• Use problem-solving methodologies (e.g., Five Whys, Fishbone diagrams) for root cause analysis.
• Use statistical tools (e.g., Minitab) to analyze data and generate actionable insights.
• Establish and maintain Overall Equipment Effectiveness (OEE) improvement plans and track performance metrics.
• Develop and maintain standardized procedures and documentation.

Maintenance

• Develop and implement comprehensive preventive maintenance plans for manufacturing and test equipment.
• Coordinate with maintenance teams for scheduled maintenance, service, and calibrations.