POSITION SUMMARY:

We are looking for a driven and talented Manufacturing Execution System Engineer to join the ArcherDX Assay Manufacturing group in Boulder, CO.

The Assay Manufacturing group is responsible for making rapid and high-quality assays utilizing our Anchored Multiplex PCR (AMP™) technology for use in oncology, immunology, and constitutional genomics.

The MES Engineer will play a key role in delivering best in class systems and processes for high throughput NGS panel manufacturing, paving the way for the personalized healthcare revolution. The ideal candidate will have prior experience in a cGMP-regulated environment using and administering electronic systems and controls. This role will require cross-functional leadership skills in order to develop and implement manufacturing systems solutions. 

RESPONSIBILITES:

• Coordinate implementation and lifecycle management of MES by creating relevant documentation, creating and delivering end user training, and managing user accounts.
• Develop material masters, equipment classes, and master recipes for tracking and documenting production activities.
• Author/review/own system related documentation such as SOPs, business process documents, and training materials.
• Provide end-user support to manufacturing operators, logistics specialists, and quality assurance personnel.
• Support system related requests such as data retrieval and customer inquiries.
• Assess and implement changes under approved change control.
• Resolve issues to ensure uninterrupted demand fulfillment.
• Recommend and implement process improvements to optimize RUO manufacturing for speed, quality, sustainability, and scalability.
• Develop and maintain Key Performance Indicators (KPIs) to facilitate continuous improvement of manufacturing systems and processes. 
• Actively communicate with key stakeholders to identify challenges and opportunities related to the manufacturing operations.
• Support digital transformation roadmap activities for other departments and functional groups as needed.

KEY ATTRIBUTES:

• Understanding of ERP, QMS, and Process Control
• Ability to work in a fast paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Strong communication and presentation skills
• Driven to perform
• Self-directed: needs little explicit direction
• Able to organize, prioritize, and delegate tasks to efficiently move projects forward

MINIMUM REQUIREMENTS:

• Bachelor’s degree Computer Science, Electrical Engineering, Industrial Engineering or relevant science related field
• 2+ years experience implementing software systems and performing tasks in a regulated production environment
• Experience working in a cGMP environment
• Experience supporting electronic batch record systems
• Working knowledge of MS Office and ERP systems
• Ability to apply basic scientific and regulatory principles to solve system issues

PREFERRED QUALIFICATIONS:

• Experience in the medical device, biotech, or pharmaceutical industries
• Experience implementing and supporting Syncade, PharmaSuite, PAS-X, or similar MES platforms
• Experience implementing interfaces between MES, ERP, and process control systems