Validation Engineer

Job Title: Validation EngineerLocation: Devens, MADuration: 6 months100% onsite- some WFH flexibility but not hybrid.Rate: $69.93/hr on w2Interview process: 1-2 rounds of interviews. Qualification, decommissioning, software upgrades on equipmentManage multiple instrument qualifications. Computerized system Validation experience is a big plusMaximo, Veeva big plusNo specific equipment experience is needed. Education, Qualifications and Experience Required:      Bachelors degree or Masters degree in Engineering, Chemistry, Biology, or in a related, scientific/computer-based field.      Minimum of 5 years experience in the biopharmaceutical industry or equivalent combination of education and validation/Computer System Validation (CSV)/lab experience will be considered.      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.      Must have equipment validation experience.      Must have CSV experience.      Must have GMP experience.      Must have Quality Management System (QMS) experience.      Working knowledge of laboratory systems such as: Empower, NuGenesis, and other software programs, including      Microsoft Office Applications, preferred.      Experience in asset management software is a plus.