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.

• Identify and analyze process inefficiencies in the production of bottled liquids, tablets, suppositories, and tubed products.
• Develop standard operating procedures (SOPs), Master Batch Records (M ’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.

• 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.

• 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.

• 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.

• 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.

• Work with multidisciplinary teams to execute high‑complexity medium to large scale improvement projects.
• Track the progress and ensure timely delivery of assigned work streams.
• Measure results and provide cost‑benefit analysis of improvement initiatives.

• 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.

• 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…