Validation Engineer

Location: Cambridge, Massachusetts, United States
Salary: competitive
Job Type: Contract
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Title: Validation Analyst

Location: Alston, MA

Duration: 6 months

RESPONSIBILITIES

  • Coordinate activities relating to the qualification, calibration and maintenance of computerized laboratory equipment and related systems.
  • Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. Routinely assumes leadership role for instrument qualification.
  • Demonstrate an understanding of CGMP's and 21 CFR compliance and how it applies to laboratory instruments
  • Schedule/plan/execute computer validation activities of computerized laboratory equipment.
  • Monitor and ensure ongoing compliance of all laboratory equipment and associated systems.
  • Develops and authors complex and explicit documentation to support instrument qualification and software validation.
  • Author protocols and technical reports related to the implementation of QC equipment
  • Authors GXP Criticality and ERES assessments.
  • Work independently with minimal supervision and direction.
  • Practice safe work habits and adhere to safety procedures and guidelines Exercise sound judgment and decision making when problem solving

BASIC QUALIFICATIONS

  • Bachelor's Degree in Chemistry, Life Sciences, or IT discipline and 3 years of Industry relevant experience Or Master's Degree in Chemistry, Life Sciences, or IT discipline and 1 years of Industry relevant experience
  • Minimum of 1 year of experience related to instrument software validation in a regulated environment such as GMP.

PREFERRED QUALIFICATIONS

  • Demonstrated scientific technical writing ability.
  • Knowledge of USP 1058 and GAMP methodology. Knowledge of 21CFR Parts 11,210,211,600 and 610.
  • Previous hands on experience performing laboratory equipment qualification, including software validation.
  • Proficient in Outlook and Microsoft Office and lab based data management systems.
  • Proficient in MS Office and Lab based data management systems
  • Ability to present technical data
  • Ability to work independently on scientific projects
  • Familiarity with USP and global compendial regulations
  • Scientific technical writing ability including authoring and revising SOP's or technical reports
  • Special Working Conditions
  • Must be able to lift 40lbs
  • Must be able to gown for entry into the QC lab area
  • Must be able to work on a flexible schedule on a periodic basis based on business need

Sthree US is acting as an Employment Business in relation to this vacancy.

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