Production Engineer II

Posted 3 Days Ago
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Minneapolis, MN, USA
In-Office
Senior level
Healthtech • Pharmaceutical
The Role
Lead cross-functional continuous improvement projects across pharmaceutical manufacturing lines using SPC, DOE, FMEA, lean and Six Sigma methods. Develop SOPs and MBRs, mentor junior engineers, integrate automation, track KPIs, drive cost-saving initiatives, ensure GMP/FDA compliance, and provide production troubleshooting and documentation.
Summary Generated by Built In

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:

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five “core” competencies. We strive to bring employees on board the journey with us who exemplify these key 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…

 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. Please consider joining our team where great things are happening and you can make a difference.

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.

Qualifications Experience Required Engineer in a production or manufacturing environment Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Skills Required

  • Bachelor's degree in an engineering discipline (mechanical, chemical, industrial, electrical) or 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)
  • Production or manufacturing experience in pharmaceutical industry
  • Certification in lean manufacturing, Six Sigma (Green Belt or equivalent)
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The Company
HQ: Allegan, MI
413 Employees

What We Do

At Padagis our focus is on health care products that improve people’s lives. We are experts on extended topical products and are strategically investing to expand our #1 position in the extended topical category in the United States. Our team members, numbering more than 1,300 work in a dynamic environment where opportunity is built on a foundation of honesty and transparency.

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