- 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.
- 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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Validation Engineer - Ayer, United States - Katalyst Healthcares and Life Sciences
