Engineering - validation Engineer - TechDigital
Devens, MA
About the Job
Se nior QC Instrument Lifecycle Validation Engineer
Devens, MA
Hybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)
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 report
Author/execute computer system validation scripts
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
Complete decommissioning/periodic assessments
Education, Qualifications and Experience Required:
Bachelor's degree in relevant scientific, engineering, or computer-based area with 6 10+ 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 equipment validation experience
Must have GMP experience
Must have Quality Management System (QMS) experience
Experience in Computer System Validation is a plus.
Experience in any asset management software is a plus.
Devens, MA
Hybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)
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 report
Author/execute computer system validation scripts
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
Complete decommissioning/periodic assessments
Education, Qualifications and Experience Required:
Bachelor's degree in relevant scientific, engineering, or computer-based area with 6 10+ 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 equipment validation experience
Must have GMP experience
Must have Quality Management System (QMS) experience
Experience in Computer System Validation is a plus.
Experience in any asset management software is a plus.
Source : TechDigital