Production Engineer II
About the role
We are seeking an experienced Production Engineer with a strong focus on Continuous Improvement to join our team in New Hope, MN.
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.
- 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.
- Aid 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).
About us
At Padagis, our focus is on health care products that improve people’s lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products. It’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency.
What's Next
At Padagis, a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.