Summary of Major Responsibilities
The Automation/Projects Engineer will serve a dual role provide automation support while managing automation related projects. The Automation/Projects Engineer will develop requirements in support of manufacturing, process utilities and lab systems while partnering with both internal and external stakeholders. Additionally, the Automation/Projects Engineer is responsible for the supervision of maintenance, repair, service, monitoring and programming of automated production components and systems for Exact Sciences Corp. and Exact Sciences Laboratories. As an Automation/Project Engineer, this position will manage multiple engineering projects and initiatives relating the areas of process, automation and system improvements. This will include development of plans & timelines, organizes and controls project elements while ensuring work complies with established practices, policies and processes.
Essential Duties and Responsibilities
Based on stakeholders' input and in collaboration with internal and external partners will conceive, specify, procure and implement engineering controls installation and modifications to support new manufacturing solutions, process automation/improvement, clinical laboratory test procedure automation, volume growth and new product introduction.
Support existing automation installations including implementation of new products, hands-on troubleshooting, equipment set up and adjustment, repair, planned maintenance and performance monitoring.
Lead projects to analyze, troubleshoot and improve processes, including manual and automated/semi-automated reagent formulation, dispensing, labeling and packaging in a cGMP environment and/or clinical laboratory diagnostic sample testing automation in a CAP/CLIA environment.
Use engineering knowledge and assist in consolidation of generated project data for interface with functional specialist on cross-functional teams, to ensure stakeholder understanding of trade-offs amongst cost, schedule, quality and risk.
Coordinate all aspects of project delivery from inception to turnover in accordance with accepted project management principles and internal practices.
Participate in defining and drafts the scope with the project team, applying appropriate standards, guidelines, regulations and procedures to ensure all the work and only the work required to complete the project is included in the baseline.
Monitor milestones and task activities to ensure timely completion of project deliverables.
Develop and maintain documentation (standard operating procedures, user requirements, design specifications, component specification and selection, commissioning protocols, etc.) necessary to ensure consistent, high-quality projects.
Provide technical support, ensuring appropriate change control practices are followed for manufacturing processes.
Lead or participate in investigations and troubleshooting of manufacturing processes associated with internal review, CAPA, audits or complaints.
Collaborate with R&D and Operations/Lab Operations to ensure design for manufacturability elements are incorporated into product requirements and development activities to facilitate smooth transfer of products and processes into new or existing automation systems.
Lead or support new equipment specification, design, installation, commissioning and qualification activities.
Establish baseline schedules and identifies critical path, using Microsoft Project, to integrate elements of the work breakdown structure and resources.
Carry out other duties, responsibilities and projects as may be assigned, in an effective manner.
Support and comply with the company's Quality Management System policies and procedures.
Regular and reliable attendance.
Ability to work nights and/or weekends.
Ability to work normal schedule of Monday through Friday during normal business hours.
Ability to lift up to 50 pounds for approximately 10% of a typical working day.
Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
Ability to work in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability to comply with any applicable personal protective equipment requirements.
Ability to travel approximately 10% of working time.
Bachelor of Science degree in an Engineering discipline.
5+ years of work experience in a project environment preferably in a regulated environment.
Operating knowledge of Allen Bradley and Wonderware automation systems.
Project management skills.
Solid communication skills and ability to communicate effectively across all organizational levels, as well as with external suppliers.
Authorization to work in the United States without sponsorship.
Working knowledge of MSProject.
Experience working in a cGMP / ISO 13485 compliant manufacturing environment.
Project Management certification (e.g. CPMP, PMP).
Experience with contract manufacturing.
Experience with equipment procurement.
Experience with managing cross functional / multi-sites project.
Bachelor of Science in the area of Chemical or Mechanical Engineering.