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Infrastructure Engineer / Systems Engineer (# 6413)

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Position Details:

Title: Infrastructure Engineer / Systems Engineer

Location: Newark, CA 94560 (Hybrid – 3 days/week onsite)

Duration: 7 Months Contract (Possible extension)


Job Description:

Top Skills:

  • Looking for someone who has managed network infrastructure.
  • The role requires someone who can play a lead role.
  • The candidate should be capable of managing SOP updates, work infrastructure, and IT infrastructure.
  • Top skills required include excellent communication skills, hands-on experience with IT Infrastructure systems (Servers, AD, Backups, VMware), and experience with SOP processes.
  • The candidate should have experience with change management and configuration management.
  • Top 3 skills are: Infrastructure experience, SOP updates and Good Communication skills.
  • Nice to have (Not required): Familiarity with Annex 11 and Part 11

Duties:

  • Provide independent technical leadership and accountability for overall IT Infrastructure Qualification and CSV efforts
  • Ensure quality and compliance is met in accordance with established procedures and standards of the Quality Systems by applying critical thinking on qualification and validation work
  • Plan, generate, review and/or approve qualification or validation packages for IT Infrastructure or GxP systems in support of compliance activities
  • Develop or assist with change controls, CAPAs, deviations, exceptions required as part of qualification/validation efforts
  • Engage with IT stakeholders in supporting continuous improvements to the existing procedures and policies in relation to compliance and update those as necessary
  • Perform gap analysis & necessary remediation efforts on current IT Infrastructure to ensure compliance with Part 11 and Annex 11
  • Collaborate/lead/participate in decision making and make recommendations regarding best options for qualification of computerized systems.
  • Maintain close communication with stakeholders and team members to keep apprised of IT Infrastructure needs, & impact on GxP processes or operations
  • Collaborate with Client approved vendor personnel in coordinating qualification or validation efforts to ensure successful system implementations
  • Perform system assessments based on version upgrades/release updates on SaaS/Cloud based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted
  • Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments etc.
  • Assist IT staff with business process deliverables such as process flows, data flows, user/operating procedures, work instructions and forms for GxP computerized systems
  • Perform System Periodic Reviews ensuring that the systems are maintained in their validated state
  • Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV

 

Skills:

  • Minimum of seven (5-7) years or more in the pharmaceutical industry with GMP experience
  • Understanding of Validation Life Cycle approach and practical working knowledge of computer system validation/computer software assurance requirements
  • Knowledge of infrastructure qualification or validation of computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
  • Demonstrate ability to effectively manage multiple projects/priorities and good understanding of SDLC phases and phase gates
  • Experience with EDMS, VLMS, LMS and working knowledge of IT Infrastructure systems (AD, Backups, VMware, Monitoring at minimum)
  • Demonstrate excellent written and oral communication skills.
  • Effective time management and interpersonal skills.
  • Must work effectively within teams with rapidly changing priorities.
  • Demonstrates analytical problem-solving skills.

 

Keywords:

Education: Preferred Qualifications:

  • Minimum Required: Bachelor's degree in Engineering, Science or related technological field.
  • Preferred: Bachelor degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS) or any related field.

 

Skills and Experience:

Required Skills:

  • FDA
  • TIME MANAGEMENT
  • EDMS
  • PROBLEM-SOLVING
  • VMWARE


Additional Skills:

    • GMP
    • IT INFRASTRUCTURE
    • QA ENGINEERING
    • SDLC
    • AUDIT
    • LIFE CYCLE
    • LMS
    • BACKUPS
    • EXCELLENT WRITTEN
    • COMPUTER VALIDATION
    • BIOMEDICAL
    • SYSTEM VALIDATION
    • GAP ANALYSIS

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