Manufacturing Engineer

Operations Engineer, Test Validation shall act as the operations group validation representative to the contract manufacturing site and is responsible for overall test validation readiness on new and sustaining products. This role shall supervise the contract manufacturing site to ensure optimal production, driving continuous improvement and improve product quality on the products manufactured by the contract manufacturing partner.  

Operations Engineer, Test Validation is responsible to develop and support test validation strategies, automated test equipment and supporting processes / procedures for mixed model scientific instrumentation.  Test equipment is developed around a broad set of technologies used within our products which include PCBA’s, electromechanical assemblies, flow measurement, optics, chemistry, pneumatics and others. 

The Operations Engineer, Test Validation shall have oversight to all related calibration and validation related changes and deviations that impact product quality for the contract manufacturing sites.

Execute approved process validation and equipment qualification protocols to meet applicable regulatory requirements.
• Assess and deliver any amendments to the qualifications to deliver fully validated equipment into production within agreed timelines.
• Provide technical guidance as a subject matter expert to contract manufacturer’s sites with respect to equipment qualification as it pertains to test equipment in production.
• Assist in continuously improving the efficiency and effectiveness of test execution, data gathering, reporting and bug tracking.
• Support and work with cross functional team including technical personnel from various disciplines and backgrounds.
• Able to within a team .
• Prioritize needs and effectively schedule work to support multiple projects at one time.
Prepare test sample and test solvent for instrument testing.
Manage Calibration and Preventive Maintenance of equipment.
Other responsibilities as required

Education: Minimum of bachelor’s degree in engineering or computer science (e.g. Chemical Engineering, Electrical Engineering, Biomedical Engineering, Mechanical Engineering)

Experience: 3 to 5 years working experience.
Basic knowledge of with equipment and software Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ) protocol validation methods.
Basic knowledge of with AQL and RQL is a plus.
Complexity: Understanding of quality systems, risk assessment and root cause analysis.
Excellent (verbal and written) communication and interpersonal skills.
Ability to manage several projects simultaneously

Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.   

Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow. 

Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.