Validation Scientist/Engineer

Company Name:
For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 5,000 employees and is represented in 85 countries around the world.
Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Waters Corporation is currently leading a search for a Validation Scientist/Engineer to join our organization. As a key member of the Lab-Based Systems Qualification Group, the individual will assist in the development and validation of Waters Qualification Products. Specifically, the individual will perform compliance product validation for our LC-MS instrumentation/systems. This role will interface with multiple stakeholders throughout Sustaining, Global Service Support, Product Development and Quality.
Assemble LC-MS systems, including required software, to perform compliance product validation.
Perform critical review of process and procedures as well as documentation.
Ensure critical deadlines are met for qualification validation efforts.
Plan, schedule and perform qualification product validation.
Ensure that lab equipment is maintained and fully functional.
Generate validation reports specific to system level qualification products
Execute and document the qualification and validation of LC-MS systems equipment, processes, and manufactured components to meet the requirements defined by our Quality Manual and our Customers' requirements
Ensure that applicable regulations, guidelines and company procedures are followed and applied during all stages of validation activities
Create qualification and validation deliverables, such as validation project plans, risk assessments, validation (e.g., IQ, OQ) protocols, commissioning plans, commissioning and validation summary reports, etc.
Work with cross-functional teams to evaluate and set milestones to ensure validation projects are on schedule and meet quality compliance requirements
Identify and coordinate activities required to complete qualification and validation activities, including reviews with Quality, obtaining signature approvals, and executing qualification protocols or validation project plans
Support risk assessment and control activities
Bachelors Degree preferably within Chemistry, Analytical Chemistry, Biochemistry or related field of study
5+ years experience with LC-MS instrumentation/systems, preferably with experience validating LC-MS systems. Experience creating qualification, validation, IQ, OQ, commission plans nice to have.
Ability to perform system maintenance and troubleshooting; including hardware and software.
Proficiency with MassLynx, Empower, and /or UNIFI software.
Strong organizational and communication skills required
Detail oriented with ability to work independently and multitask in a fast-paced environment.
High proficiency with Microsoft Office.
Date: 2014-08-28
Country: US
State: MA
City: Milford
Postal Code: 01757
Category: Field Support
Job Type: Regular Full-Time

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