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System One Services Computer System Validation Engineer in Canton, Massachusetts

Computer System Validation EngineerCanton, MA

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:218178

Date Posted:06/08/2021

Computer System Validation Engineer

Requirements:

  • Minimum of a AS/BS degree w/ 3-5 yrs. exp. validating GXP computer systems

  • Must have previous computer system validation exp. in Pharma/Biologics/Med Device industry

  • Familiar with GAMP Computer System Principles

  • High level competency with qualification of the following types of computer system qualifications: ERP systems, EM Databases (MODA), Document Management Systems (e.g. Pilgrim), and Deviation, NCR, complaint handling programs.

Primary Duties/Responsibilities:

  • Prepares protocols and reports for initial validation, requalification, and revalidation work

  • Designated to support validations for two CGMP facilities

  • Performs testing using standard computer qualification concepts, practices and procedures of the CGMP process and is consistent with established client testing methodologies

  • Responsible for researching, developing, and executing Installation, Operational, Performance Qualification, Requalification and Revalidation protocols for stand-alone Computer Systems (local server(s) and cloud based) and embedded computer systems in manufacturing equipment (as applicable)

  • Responsible for the generation and maintenance of traceability matrices

  • Reviews and assesses vendor supplied computer system validation documentation for alignment with client requirements. Generates client gap protocols where deficiencies are identified

  • Reviews and summarizes the output of completed executed computer system scripts for vendor supplied documentation

Location:Canton, MA area

Start Date:ASAP!!

Duration:Direct Hire

Hours:Mon-Fri; 8am-5pm

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