Senior Validation Engineer - Phoenix, AZ, United States - Exact Sciences

Description

Help us change lives

At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Senior Engineer, Process Development and Automation coordinates, manages, implements, and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. This position works and collaborates cross-functionally with internal and external partners to enhance existing workflows and develop new automated workflows in a complex, rapidly evolving clinical laboratory. The Senior Engineer responsibilities are validation, configuration management, and partner with various groups for process improvement and system development for the Next Generation Sequencing clinical laboratories in Phoenix. Once resources are identified, this role can get a project off the ground and running with minimal support from management. The Senior Engineer, Process Development and Automation can make new processes, systems, validation methods or projects successful.

Essential Duties

include but are not limited to the following:

• Responsible for equipment and process validations in NGS clinical laboratories.
• Partner with leadership, functional and program managers to identify appropriate scope of testing, verification and validation required for a project, and managing the overall testing activities.
• Prepare, maintain, and review documentation on validation and compliance; including validation plans, risk assessments, specifications, protocols, reports, trace matrices, and change controls to ensure compliance with applicable business and regulatory requirements.
• Contributes ideas and insights to new technologies, testing methodologies, applications, techniques, or procedures that are creative and practical.
• Provides input for project design & development.
• Accurately estimates task effort, including work by others.
• Develops process architectures and functional specifications based on user and workflow requirements.
• Leads planning activities and conducts complex engineering design, platform eligibility testing, systems integration, or performance testing.
• Makes decisions that involve the consideration of complex issues.
• Works autonomously and checks-in with supervisor/project lead as decisions are made.
• Responds to change with flexibility and adapts quickly.
• Discusses and presents factual information to other members of the same organization; Ability to convey very complex information in both written and oral form.
• Actively and constructively contributes to other's designs through design reviews within same organization.
• Facilitates reuse by communicating available technologies and opportunities within the organization.
• Able to influence others and gain acceptance and build consensus.
• Ability to manage moderately complex projects and initiatives, typically within one platform or business organization.
• Acts as a mentor / role model for junior team members on technical issues.
• Ability to apply project leadership skills in planning, delegating, influencing, and managing priorities.
• Beginning to demonstrate leadership behaviors: humility, will, best team and vision.
• Demonstrates understanding of company's internal and external customer needs and how they affect business unit products and services.
• Brings company and industry knowledge as well as creative technical/scientific skills to product creation; recognized as a content, sub-discipline specialist across the company.
• Work with project managers and cross-functional teams on user requirements, factory acceptance tests, validation planning, site acceptance tests, pre-installation planning, initial installation, setup, maintenance, and improvement for new or upgraded instrumentation and automation systems.
• Independently address routine issues utilizing documented procedures and researching historical cases.
• Provide support and response to complex system problems, counseling the internal and external vendors and Laboratory Service Engineers on corrective and preventative actions.
• Provide mentoring and technical guidance to service engineers, laboratory technicians, and other members of the Process Development and Automation team.
• Maintain oversight for quality of both mechanical repairs and related documentation.
• Lead recommendation and implementation changes to ensure ongoing high-quality performance of laboratory equipment.
• Lead technical investigation and troubleshooting of laboratory systems.
• Lead continuous improvement projects that drive cost reduction and lab efficiency.
• Ensure both new and existing instrumentation automation and non-automation meet safety requirements and compliance standards.
• Maintain records and follow laboratory procedures to meet regulatory requirements such as FDA, CLIA, and/or CAP.
• Maintain and continuously develop personal knowledge and expertise related to the service of complex clinical laboratory equipment.
• Ability to manage time effectively between competing priorities.
• Excellent verbal and written English communication skills.
• Ability to manage and adhere to maintenance schedule.
• Ability to define problems, collect data, establish facts, and draw data driven conclusions.
• Have demonstrated ability to follow procedures and maintain detailed records.
• Have demonstrated ability to manage time and competing priorities.
• Must be highly motivated and able to work both independently and as a member of a team.
• Adaptable, open to change and able to work in ambiguous situations and respond to new information and unexpected circumstances.
• Proven capability to take scientific bench protocols from the bench to automation system.
• Effectively communicate issues/problems and results that impact timelines, accuracy, and reliability of data.
• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding environment with changing priorities.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Regular and reliable attendance.
• Occasional evening and weekend work may be required.
• Ability to lift up to 50 pounds for < 5% 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 80% of a typical working day.
• Ability to comply with all applicable personal protective equipment requirements.
• Ability to travel approximately 10% of working time for occasional training, out of state vendor site visits, and travel between Exact Sciences sites.

Minimum Qualifications

• Bachelor's degree in Engineering or related field; or Associates degree in Engineering, Technology, Electronics, or similar field and 2 years of experience.
• 6+ years of experience in engineering or relevant industry.
• Possesses advanced knowledge of engineering theories, practices and procedures and applies this knowledge and skills to complete assignments.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Bachelor's degree in Engineering or related field and 10+ years of relevant experience; or Associates degree in Engineering, Technology, Electronics, or similar field with 12+ years of relevant industry experience.
• Technical proficiency and experience in automation, system development, and integration in a laboratory environment.
• Experience in process optimization involving complex workflows comprising both system equipment and software components to ensure user and business requirements are met.
• Experience working in a CAP/CLIA and/or other regulated production environment.
• Advanced knowledge of database, laboratory information management systems, and other file management applications.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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