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 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 expert…