Production Engineer II

We are seeking an experienced Production Engineer with a strong focus on Continuous Improvement to join our team in New Hope, MN. In this role, you will be focused on driving large-scale, strategic process improvement initiatives across the manufacturing network. This role encompasses leading cross-functional teams, advising on advanced engineering problems, and influencing broader organizational goals. Level 2 engineers are responsible for designing and executing high-impact projects, mentoring lower-level engineering staff, and contributing to long-term operational strategies.

Job duties:

Strategic Process Improvement Leadership 

• Identify and analyze process inefficiencies in the production of bottled liquids, tablets, suppositories, and tubed products.

• Develop standard operating procedures (SOPs), Master Batch Records (MBR’s), and Operations Manuals (Oms) to drive best practices across manufacturing lines.

• Actively participate in structured training programs focused on pharmaceutical production, lean tools, and continuous improvement methodologies.

• Lead large and complex continuous improvement initiatives, ensuring alignment with business goals and Key Performance Indicators (KPIs).

• Drive long-term operational improvements by identifying systemic inefficiencies and applying cutting-edge engineering and lean techniques.

• Collaborate with senior leadership to develop and implement overarching strategies for operational excellence.

Advancing Continuous Improvement Practices 

• Utilize advanced tools such as Statistical Process Control (SPC), Design of Experiments (DOE), and Failure Mode and Effects Analysis (FMEA) to solve complex manufacturing challenges. 

• Identify and execute cost-saving initiatives to improve efficiency and reduce waste, documenting measurable outcomes. 

• Serve as a subject matter expert in lean manufacturing and Six Sigma tools, introducing new methodologies and fostering a culture of continuous improvement. 

Cross-Functional Leadership and Mentorship 

• Mentor and coach junior engineers, ensuring skill development and long-term professional growth. 

• Act as a key resource for problem-solving and decision-making, working alongside managers and department heads. 

Innovation and Technology Integration 

• Evaluate and integrate emerging technologies, automation solutions, and best practices to enhance production efficiency. 

• Collaborate with R&D and engineering departments to implement process innovations and scalable solutions for existing and new product lines. 

KPI Tracking and Reporting 

• Monitor, analyze, and report operational performance metrics to senior leadership.  

• Develop dashboards and tools to track progress against organizational goals, including cost savings, quality improvements, and production efficiency milestones. 

Project Management 

• Work with multidisciplinary teams to execute high-complexity medium to large scale improvement projects.   

• Track the progress and ensure timely delivery of assigned workstreams.   

• Measure results and provide cost-benefit analysis of improvement initiatives. 

Compliance and Documentation 

• Maintain compliance with Good Manufacturing Practices (GMP), FDA standards, and other applicable regulations.   

• Ensure accurate documentation of process adjustments, deviations, and corrective actions as required.   

• Lead efforts to improve documentation and standard operating procedure (SOP) adherence. 

• Support audits and regulatory inspections by presenting and explaining findings and implemented improvements. 

• Ensure all collected and reported data complies with Good Manufacturing Practices (GMP) and FDA regulatory standards. 

• Complete assigned documentation tasks related to corrective actions, process changes, and improvement logs. 

 Production Support 

• Collaborate with production teams to troubleshoot and resolve process-related issues in manufacturing.   

• Assist in ensuring that all production lines meet quality, regulatory, and safety standards.   

• Play an active role in reducing downtime, waste, and variation in processes while maintaining product quality. 

• Engage with on-floor production teams to understand day-to-day challenges and provide input to improve efficiencies on a basic level. 

• Provide Subject Matter Expert (SME) guidance to set-up technicians and assist with training and troubleshooting activities in manufacturing. 

Minimum qualifications:

• Bachelor's degree in an engineering discipline (mechanical, chemical, industrial, electrical) or a related field.
• Five or more (5+) years of experience in a production or manufacturing environment.
• Subject Matter Expert (SME) on manufacturing equipment.
• Strong track record of leading complex, high-impact projects.
• Demonstrated strong problem-solving, decision-making, and leadership skills.
• Excellent communication, collaboration, and interpersonal skills.
• Proficiency in productivity tools (Excel, SAP, statistical analysis tools, etc.)

Preferred qualifications:

• Production or manufacturing experience in pharmaceutical industry.
• Certification in lean manufacturing, Six Sigma (Green Belt or equivalent).