Process Engineer (Process Development Engineer

Process Engineer (Process Development Engineer)

Location:

Tucson, AZ

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 escalate 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.