Production Engineer II

Padagis LLC; Minneapolis (MN); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Padagis LLC in Minnesota seeks an experienced Production Engineer with a strong focus on Continuous Improvement to lead large-scale process improvements across the manufacturing network. You will mentor staff, influence operations strategy, and partner with cross-functional teams to drive efficiency, quality, and regulatory compliance.

The role emphasizes hands-on problem solving, data-driven decision making, and the design and execution of high-impact projects within GMP guidelines.

Qualifications

• Bachelor's degree in an engineering discipline.
• 5+ years in production or manufacturing.
• SME on manufacturing equipment.
• Proven track record leading high-impact projects.
• Strong problem solving, decision making, and leadership.
• Excellent communication and collaboration.
• Proficient with productivity tools such as Excel and SAP.

Responsabilités

• Lead large-scale continuous improvement initiatives across manufacturing network.
• Develop SOPs, MBRs, and operations manuals to drive best practices.
• Mentor junior engineers and collaborate with senior leadership.
• Identify KPIs and track performance with dashboards.
• Ensure GMP/FDA compliance and proper documentation.
• Troubleshoot production issues and support on-floor teams.

Connaissances

Production experience

Strong problem-solving

Leadership

Excel

SAP

Statistical analysis tools

Communication skills

Cross-functional collaboration

Formation

Bachelor's degree in engineering

Outils

SAP

Excel

Statistical analysis tools

Description du poste

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).

Core competencies

• Service delivery – Understand who your internal and external customers are, identify their needs, and deliver value above their expectations.
• Active collaboration – Seek opportunities to work together across teams, function, business units, and geographies to seek success.
• Demonstrate agility – Proactively identify changes in our environment and act quickly, leading or embracing change.
• Think differently – Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists.
• Excellent execution – Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes.