The Senior Industrial Engineer is responsible for overseeing and optimizing the manufacturing processes of pharmaceutical products, with a focus on efficiency, quality, and compliance with
industry regulations. The Senior Industrial Engineer work to identify and solve problems in production processes, reduce waste, increase productivity, and improve product quality while
ensuring adherence to strict safety, regulatory, and quality standards. This position is responsible for working on the design, implementation, and continuous improvement of manufacturing
processes, equipment, and facilities. They will develop and optimize production schedules, equipment utilization, and be responsible for ensuring that all manufacturing processes are
compliant with relevant regulatory requirements such as FDA and GMP guidelines.

Essential Duties:

• Develop and optimize manufacturing processes for pharmaceutical products, while ensuring compliance with safety, quality, and regulatory requirements.
• Conduct process and equipment activities to ensure that manufacturing processes are reproducible, consistent, and meet regulatory requirements.
• Design and implement manufacturing layouts, equipment specifications, and automation solutions to improve efficiency, reduce costs, and enhance product quality.
• Identify and analyze process performance metrics such as yield, throughput, cycle time, and cost to identify areas for improvement and optimization.
• Cross-functional/cross-regional problem solving - work directly with Manufacturing, Packaging, Engineering, Maintenance, Supply Chain to resolve open issues that impact Manufacturing
• and Packaging activities.
• Continuously monitor and analyze industry trends, regulatory updates, and technological advancements to ensure that the organization's manufacturing processes remain up-to-date and
• competitive.
• Lead and manage process improvement projects to drive continuous improvement in efficiency, cost reduction, and quality enhancement.
• Develop and implement risk management strategies to ensure that potential risks to product quality, safety, and efficacy are identified and addressed appropriately.
• Participate in regulatory inspections and audits and support the development of responses to regulatory inquiries related to manufacturing processes.
• Support activities as needed for exceptions, observation notifications, CAPA, and other follow up activities for manufacturing operations.

Requirements:

Bachelor of Science degree in Industrial Engineering or equivalent required. 5 years of manufacturing experience; experience in compounding and/or packaging experience in a cGMP
manufacturing environment preferred.
Strong knowledge of pharmaceutical manufacturing processes and equipment, as well as relevant regulatory requirements and guidelines such as FDA and GMP required.
Preferred experience in leading cross-functional teams and managing projects related to process development, optimization, and improvement

Other Knowledge, Skills and Abilities:
• Organized; Thorough
• Self-starter/Takes initiative; Motivated
• Proficient in Microsoft applications - Excel, PowerPoint, Word
• Engineering degree or equivalent - Industrial, Mechanical, Electrical preferred
• Manufacturing experience preferred
• New Product Development experience preferred
• Industrialization/Automation knowledge a plus

Certifications / Licenses:
Lean manufacturing, six sigma and related process evaluation/improvement certifications are preferred but not required.
 

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.