Senior Validation Scientist
Company: Waters Technologies Corporation D/B/A Waters Corporation
Location: Milford, MA
Posted on: May 24, 2017
Job Description:
Duties: Under the supervision of the Team Leader-Services
Engineering, Global Services, assist in the development and validation of
Waters Qualification Products. Perform compliance product validation
for LC-MS instrumentation/systems. Interface with multiple stakeholders
throughout Sustaining, Global Service Support, Product Development and
Quality Assurance. 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. Ensure that lab supplies
are maintained and available 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,
and commissioning and validation summary reports. 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. Requirements: No degree and seven (7) years of experience troubleshooting hardware and chemical issues related to mass spectrometers or, a Bachelor's degree in Chemistry or related
scientific field (willing to accept foreign education equivalent) and five
(5) years of experience as stated above or, a Master’s degree in one
of the enumerated fields and three (3) years of experience as noted
above. Also requires: Demonstrated Expertise (DE) repairing and maintaining
tandem quadrupole and Quadrupole-TOF mass spectrometers; DE repairing
and maintaining SFC systems; DE utilizing software platforms to
merge LC and high performance MS data as well as chromatography data software
for scientific laboratory-based organizations and instrument
control; DE repairing, maintaining, and operating UPLC technology systems;
and DE utilizing a compliant-ready data repository and a flexible
analytical electronic laboratory notebook to capture and archive data.
Position requires up to 20% domestic/international travel. Please apply at :
https://globalcareers-waters.icims.com/jobs.
Keywords: Waters Technologies Corporation D/B/A Waters Corporation, Framingham , Senior Validation Scientist, Science, Research & Development , Milford, MA, Massachusetts
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