Validation Engineer

2 weeks ago


Foster City, United States Integrated Resources, Inc ( IRI ) Full time

Title: Validation Engineer - III


Location: Foster City, CA


Duration: 12+ Months



Top 3 Required Skill Sets:

  • Computer system validation using GAMP 5 methodology
  • 21 CFR part 11 and Annex 11
  • Change Control and Impact Assessments



Top 3 Nice to Have Skill Sets:

  • Process Control Systems / Environmental Monitoring Systems technical proficiency
  • Data Migration experience
  • Project Management



Unique Selling Point of this role:

Computer system validation expertise with experience in validating a variety of computer systems.



Required Degree or Certification:

Bachelor’s degree in computer science or Pharma/Biotech related field




Description:

  • Responsible for authoring and/or revising the following documents related to GxP Systems (specifically Client iFix & Rockwell FactoryTalk View based Environmental Monitoring Systems): User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, Installation, Operational and Performance Qualification protocols.
  • Responsible for execution of authored protocols.
  • Author change management records, creates or revises impacted documentation and executes change implementation tasks.
  • Develop decommissioning and data migration strategies for legacy systems and author validation deliverables for decommissioning systems.
  • Collaborate with cross-functional teams in authoring CAPAs and Deviations.
  • Perform periodic system maintenance activities such as, account management, system maintenance, system audit trail review and backup and restore testing, etc.
  • Maintain system specific operational documentation such as SOPs, work instructions, business-enabling documents, training plan as well as contribute to authoring and maintenance of business SOPs.
  • Coordinate with IT stakeholders for maintenance of system infrastructure, security, and vulnerability management.
  • Coordinate with business stakeholders to constantly align with their needs and deliver technical and compliant solutions, as required.
  • Coordinate with software vendors for change deployment, scheduling of system maintenance activities and issue management.


Experience:

  • Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems.
  • System Administration experience is preferred but not required.
  • Must be experienced in computer system validation using GAMP 5 methodology.
  • Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to environmental monitoring systems.
  • Experienced in developing validation methodology for global implementation of systems.
  • Experience with validation methodologies and SDLC best practices.
  • Proficient in current Good Manufacturing Practices (cGMPs) requirements.


Any Disqualifiers?

Inadequate validation experience or testing skills

Lack of industry standards knowledge (GAMP5, 21 CFR Part 11, GMP etc).


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