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Computer System Validation Engineer
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TalentBurstTewksbury, MA, United States- Full-time
Job Title : Computer System Validation Engineer II
Location : Tewksbury, MA (Remote)
Duration : 06+ Months
W2 Acceptable (No Sponsorship Required)
Remote position. Must be willing to work EST schedule.
Job Description :
Occasional travel may be required.
Possibility of extension based on demand.
This position uses industry best practice and quality engineering principles to create and enforce a rigorous software validation program as part of overall product quality architecture commensurate to ever-evolving customer and business needs. This includes, but is not limited to, all stages of product Innovation (& Design / Development Controls) and business / manufacturing / quality software system implementation.
This position works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement and Business Operations) to develop and implement a standardized, lean, compliant approach to verifying software meets or exceeds internal / external customer and regulatory expectations.
DESCRIPTION OF WORK :
- Standardization and streamlining of validation processes across life science division(s) to assure conforming, compliant software is made available to internal / external customers in a timely manner
- Coordinate with various functional groups to ensure understanding, documentation, and verification / validation of software requirements
- Self-initiative for continuous improvement within the organization
- Act as Quality representative on projects of varying scale and complexity
- Champion and proponent of software IQ / OQ / PQ validation systems within the organization as SME, Trainer, and Coach
- Apply best quality engineering practices and guidance to support project teams in software user requirement creation and verification / validation
- Serve as a resource for performing internal audits to ensure quality system compliance.
- Create technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements (e.g. ISO, FDA, EU, etc.)
EXPERIENCE : Required :
Preferred :
MINIMUM QUALIFICATIONS :
TB_PH