Process Engineer; Process Development Engineer

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 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.

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