Vacancy expired!
Sunrise System Inc. is currently looking for
Validation Engineer in Devens, MA with one of our top clients.Job Title: Validation EngineerJob Id: 23-02272Location: Devens, MA 01434Duration: 12 monthsPosition Type: Hourly contract Position (W2 only) QC Lifecycle Validation EngineerHybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)Responsibilities :- 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
- 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.
- ID: #49835604
- State: Massachusetts Devens 01434 Devens USA
- City: Devens
- Salary: Depends on Experience
- Job type: Contract
- Showed: 2023-05-01
- Deadline: 2023-06-27
- Category: Et cetera