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Computer Validation Specialist

Company: Automated Systems, Inc.
Location: Somerset
Posted on: November 19, 2021

Job Description:

Job Role Description: --- Ensure that site Computer System Inventory list is maintained per corporate format and remain in current state. --- As a Subject Matter Expert (SME), Computer System Validation Engineer/Specialist should be a site computer system administrator for equipment and instrument computer systems. --- Generate validation protocols in line with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations. --- Generate a CSV validation plan detailing the scope of work and intent. --- Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements. --- Ensure all work is in line with the site Master Validation Plan, regulations, procedures and practices. --- Ensure that the site Validation Master Plan remains current and aligned with corporate policies. --- Lead and conduct validation activities in compliance with US and EU regulations (regulations for all countries where have business) procedures and EHS requirements. --- Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations. --- Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan. --- Prepare validation summary reports for executed protocols. --- Liaise with manufacturing and laboratory groups in execution of the Validation program. --- Communicate Computer System Validation approaches and requirements during audits. --- Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments. --- Anticipate and assess/prevent technical problems from impacting product and processes. --- Generate and maintain Computer System Validation procedures in line with corporate guidelines procedures, CGMP, Corporate policies/standards and ISPE GAMP guideline. --- Work with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures. --- Track and resolve deviations/exceptions during qualification activities. --- Prioritize qualification activities in line with the project schedules and timelines. --- Co-ordinate validation/qualification activities with key stakeholders. --- Assist in the development of training material for qualification activities. --- Serve as the SME for CSV presentations and maintain knowledge and information in the CSV area of expertise. --- Manage Validation contractors to complete on-site validation if required. --- Equipment/Instrument Qualification, Cleaning Validation, and Process Validation. --- Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment and systems according to the GAMP5 Validation Life Cycle. 6 MONTHS - ONSITE - SHIFT - M-F 9 - 5:30PM Requirements EDUCATION: - Degree (Bachelors or Masters) in Computer/Electrical Engineering or other relevant Science Field. EXPERIENCE: - Prefer 5 to 7 years in a CGMP-related industry with at least 3 to 4 years of Computer System Validation experience working with cGMP pharmaceutical/nutraceutical regulated industries and 21 CFR Part 11 compliance (world CSV regulations). Job Requirements:

  • Evaluate personal computer software and hardware making recommendations
  • Maintain and operate LANs and associated computer hardware and software
  • Locate and resolve network connectivity or computer availability issues
  • Perform Lab computer health-check
  • Maintain, install, troubleshoot and modify computer and software
  • Maintain warranty information for all computer vendors
  • Provide software and application support
  • Work with procurement staff to purchase hardware and software
  • Provide technical support for computer-based training courseware to internal and external customers
  • Diagnose hardware and software problems and implement corrective measures
  • Updating, monitoring and general software and hardware workstations
  • Build computer displays for the security analysis package
  • Use minicomputer and mainframe computer systems in addressing project objectives
  • Monitor performance, and perform upgrades to hardware and software
  • Prepare a Benchtop computer for the retirement function
  • Refer major hardware problems to service personnel for correction
  • Investigate SCADA hardware/software problems
  • Coordinate the development of the department's personal computer support initiatives and strategies
  • Use minicomputer and mainframe computer systems in addressing project objectives
  • Formulating architectural design, functional specifications, interfaces and documentation of hardware or software systems

Keywords: Automated Systems, Inc., Trenton , Computer Validation Specialist, IT / Software / Systems , Somerset, New Jersey

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