POSITION SUMMARY

We are looking for a driven and talented Process Automation Engineer to join the Assay Manufacturing group at ArcherDX.

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 Process Automation Engineer is responsible for implementing, maintaining, and enhancing robotic systems to enable high-throughput, high-quality production of both standard and custom NGS screening panels and components. 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, implement, and optimize automated manufacturing solutions. 

RESPONSIBILITIES

• Program automated storage units, liquid handling robots, and filling and capping machines.
• Work with Manufacturing Systems Engineers to develop and implement interfaces between automated equipment and Manufacturing Execution System.
• Support manufacturing operations by troubleshooting and resolving automation issues.
• Execute system validation as required to support technology transfer activities.
• Build rapport with end-users, and coordinate with cross-functional teams
• Train operators and support staff to use and troubleshoot automated equipment.
• Develop processes and procedures for routine operation of automated equipment.
• Support digital transformation roadmap activities for other departments and functional groups as needed.

KEY ATTRIBUTES:

• Understanding of cGMPs, QMS, and Process Control
• Strong technical aptitude
• 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

REQUIREMENTS:

• Bachelor’s degree Computer Science, Electrical Engineering, Industrial Engineering or relevant science related field
• 2+ years experience implementing robotic production systems 
• Experience working in a cGMP environment
• Experience supporting electronic batch record systems
• Working knowledge of ISA-88/ISA-95
• 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 Hamilton, Tecan, or similar liquid handling units
• Experience implementing interfaces between MES and process control systems