Curium

Overview

The Senior Continuous Improvement Engineer executes the vision for translating Curium NA’s strategy and goals to efficient, sustainable, and repeatable processes. The position designs and implements engineering solutions for newly developed products, creating value by reducing execution time, cost, and errors.

Responsibilities

• Applies good engineering practices and analytical skills to identify, characterize and controlprocess variability. Uses structured tools (root cause analysis, FMEA, fault trees, etc.) to identify and mitigate potential process failures related to newly developed products.
• Collaborates with Development, Manufacturing and Compliance teams to apply continuous improvement principles (Six Sigma, Lean, etc.) to reduce execution time and improve first-time-right performance.
• Designs, tests,and implements process improvements to achieve reliability goals for newly developed products.
• Designs training for newly developed products and processes. Delivers training to manufacturing technical teams and production operators. Assists manufacturing technical teams with product support after new products are commercialized.
• Participates in root cause investigations of process deviations. Designs and implements mitigation and containment solutions.
• Utilizes technical writing strategies to create clear, concise,and complete documentation supporting production operations (batch records, SOPs, specifications, and training documents). Prepares protocols, reports, change control and other regulatory documentation to support execution of reliability activities.
• Creates preventative/predictive maintenance programs for new, critical equipment. Assists development teams with equipment qualification and validation.

Qualifications

Requirements

•Bachelor’s Degree in engineering or related scientific field required.

•Minimum of 5 years professional experience w/knowledge of pharmaceutical manufacturing and related compliance programs (FDA, NRC, EPA, OSHA) required.

•Knowledge of radiochemistry, aseptic processes, equipment procurement/construction/qualification preferred.

•Demonstrated understanding of cGMP and related regulations.

•Knowledge of reliability/continuous improvement methodologies: Six Sigma, Lean, Root Cause Analysis, Failure Mode Analysis.

•Excellent critical thinking and problem-solving skills. Demonstration of problem resolution in high stress/tight timeline situations.

•Strong business acumen, demonstrating the ability to translate technical process activities to business/financial results.

•Knowledge of project management principles related to estimating, developing, and managing schedules/resource plans.

•Proficiency in computer skills and experience with Microsoft Word, PowerPoint, and Excel.

•Strong time management, written and oral communication skills.

•Demonstrated ability to be effective as a collaborator in diverse teams.

•Agile approach and willingness to learn new things in a dynamic setting.