Location: Cambridge, Massachusetts, United States
Sectors: Engineering & Validation
Job Type: Contract
Title: Validation Analyst
Location: Alston, MA
Duration: 6 months
- 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
- 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.
- 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.