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Validation Engineer

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Offer summary

6+ years experience as a Validation Engineer, 4+ years experience with Labware LIMS, LabX.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Responsibilities:

6+ years of experience as a Validation Engineer.
4+ years of experience with Labware LIMS, LabX etc.
Plan, lead, and executed the validation efforts for standalone Lab Instrument Software systems.
Responsible for planning, scheduling, and executing validation efforts for LabX and other pharmaceutical systems.
Ensures validation is being performed per established procedure, reviews validation documentation, and coordinates between direct groups for the same.,
Identify intended use of laboratory instruments, develop qualification deliverables per current procedure and standards, and coordinate validation activities between vendors, cross-functional teams and users.
Communicate to different stakeholders and management on the progress of validation efforts
Work with the project team to identify the activities of project, dependencies, and figure out future enhancements.
Thorough understanding of FDA and EU guidelines for validation including GAMP, Data Integrity, and ASQ
Hands-on working knowledge of Trackwise, Veeva Vault, and other compliance systems.
Execute protocols or peer review protocols depending on the level of access required for execution.
Support the routing and accurate documentation of all Change Management, Deviation and Corrective Actions Preventative Actions (CAPAs).
Assist in Performing Risk and Impact assessment for validation activities and change requests.
Support Data Integrity Assurance Program for all documentation managed by their team.