TechDigital Group
Senior Validation Engineer
Hybrid Role -- 4 days onsite/ 1 day work from home (manager will adjust as the business and project needs are required) in Devens, MA
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 #J-18808-Ljbffr
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 #J-18808-Ljbffr