Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix' technology is designed to enable much earlier disease detection, better prognosis and precise treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.
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We are looking for an experienced and highly motivated Manufacturing Engineer II to join our Equipment Engineering team. This individual will support qualification and maintenance of our manufacturing equipment and manufacturing equipment processes in our kit manufacturing group. System start-ups, commissioning, qualification, requalification, and support validation projects, also the ongoing support of monitoring and calibration activities.
Commissioning is a well-planned, documented, and managed engineering approach to the start-up and turnover of systems and equipment to the End-User (all manufacturing equipment) that results in a safe and functional environment that meets established design requirements and management expectations.
What You'll Do:
- Supports the Equipment Engineering Department in providing documented evidence that all equipment and utilities used are qualified and remain in a state of control so that they deliver processes and products that comply to regulatory and product specifications
- Manage on site calibration activities, including scheduling and managing calibration vendors
- Supports the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation
- Prepare for internal and external audits and can act as the spokesperson and Subject Matter Expert during audits
- Lead and/or assist with factory and site acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting for new equipment
- Maintain the protocols and manage the environmental monitoring of the temperature-controlled equipment and areas
- Maintain the qualification status of systems that support manufacturing through regular maintenance, in compliance with any applicable standards
- Maintain accurate asset information within CMMS software database and provide instructions to others as needed
- Manage projects related to equipment implementation and other support projects
- Responsible for other duties and projects as assigned
What We'll Expect From You:
- Bachelor's Degree in Bio-Engineering or Science preferred
- Strong technical skills and interest (electrical and/or mechanical)
- Physical demands: Position requires on site coverage
- 3 years of experience in commissioning & qualification of manufacturing equipment
- Familiar with internal and external audits
- Equipment calibration experience preferred
- Quick learner, excellent communication and coordination skills, excellent interpersonal skills, and the ability to work independently under general direction
- Be required to work flexible hours to help cover manufacturing area requirements
- Ability to update SOP's (Standard Operating Procedures)
- Ability to manage outside calibration suppliers
- Ability to manage internal temperature monitoring systems
- Strong computer-based skills required. CMMS experience a plus
Why You'll Like Working For Us:
Our Technology: Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.
Our Commitment to Employees: At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!
Quanterix is committed to a Diverse and Inclusive workplace. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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