Engineering - Validation Engineer

Senior Validation Engineer Hybrid Role

Responsibilities will include (but not limited to):

• Act 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
• Author/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
• Author instrument operational SOPs as needed
• Coordinate/interface/host vendors on site
• Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client)
• Acts as the liaison between Digital Plant (IT) and lab departments
• Execute periodic assessments/decommissioning, as needed

Qualifications and Experience

Required:

• 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
• Must have GMP experience