Validation Engineer

3 weeks ago


Ayer, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:

  • ct as the project lead for qualification of QC equipment and its associated software
  • Design, execute, manage, and implement QC instrument/software qualification documents such as (but not
  • limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ
  • protocols, software test scripts, configuration specifications, risk assessments, qualification summary reports
  • uthor/execute computer system validation scripts using an electronic validation database (ALM), or paper-based
  • Own change controls specific to the qualification of QC instruments and its associated software
  • Update the asset management database to reflect new assets, calibrations, preventative maintenances
  • uthor instrument operational SOPs as needed
  • Coordinate/interface/host vendors on site
  • Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive
  • ctions (CA/Client)
  • cts as the liaison between Digital Plant (IT) and lab departments
  • Execute periodic assessments/decommissioning, as needed.
Requirements:
  • Bachelor's degree in relevant scientific, engineering, or computer-based area, with minimum of 5 years' experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience
  • Quality management system experience including: document control/management, change controls,
  • investigations, deviations, electronic validation databases, asset management database
  • Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP,
  • electronic record/electronic signature, data integrity, disaster recovery
  • Incumbents must have demonstrated experience in solving complex technical issues and have the skills and
  • understanding to troubleshoot process defects
  • Demonstrated success in cross functional influencing, strong communication, and collaboration skills
  • Working knowledge of laboratory systems such as: Empower, NuGenesis, and other software programs, including
  • Microsoft Office Applications, preferred.
  • Must have computer system validation experience
  • Must have equipment validation experience


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