QC Lifecycle Validation Engineer

NO C2C Job Description: QC 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 reports Author/execute computer system validation scripts using an electronic validation database (ALM) or paper based as required. 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 Education, Qualifications and Experience Required: Bachelor’s degree in relevant scientific, engineering, or computer-based area with 5 – 7 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. Job Type: Contract Pay: $60.00 - $65.00 per hour Schedule: 8 hour shift Monday to Friday Ability to commute/relocate: Devens, MA 01434: Reliably commute or planning to relocate before starting work (Required) Experience: Pharmaceutical: 5 years (Required) Laboratory Qualification: 5 years (Required) Change Controls/Deviations and CAPAs.: 5 years (Required) Work Location: In person