Process Development Engineer (GMP)

We are hiring a hiring a Process Development Engineer to support continuous improvement, design innovation, automation efforts, and cGMP‐aligned quality management within manufacturing processes. The position also involves driving operational excellence and ensuring robust process compliance. You will lead Lean Manufacturing initiatives to enhance overall efficiency and effectiveness. This is a 24-month contract based in Tucson, Arizona.ResponsibilitiesProcess 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 (NCR) 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.MaintenanceDevelop and implement comprehensive preventive maintenance plans for manufacturing and test equipment.Coordinate with maintenance teams for scheduled maintenance, service, and calibrations.QualificationsBachelor's Degree in Engineering/Engineering Technology or a Life Science discipline.2-5 years of relevant work experienceBasic 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).Salary$74,880-$81,120Why Choose R&D Partners?As an employee, you have access to a comprehensive benefits package including:Medical insurance – PPO, HMO & HSADental & Vision insurance401k planEmployee Assistance ProgramLong-term disabilityWeekly payrollExpense reimbursementOnline timecard approvalR&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.R&D Partners is an equal-opportunity employer.