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Validation Engineer IV

This position reports to the Associate Director, QA Computer System Validation and will be responsible for QA review and approval of GxP computer system validation activities. The position acts as a QA lead for computer system validation projects including Enterprise Applications, Lab Systems, Clinical Systems and Automation Systems.  Duties include, but are not limited to, oversight and approval of validation-related documents, conducting risk assessments to determine which elements should be validated, and conducting validation impact assessments of proposed changes to computer systems.  This position may interact with regulatory agencies and corporate partners during inspections and audits, and it may require travel for auditing vendors.


  • Conduct QA validation review and approvals for validation plans, protocols, reports, deviations, risk assessments, SDLC documentation.
  • Work with Information Technology department and system owners to effectively and efficiently implement new computer systems, system upgrades, or system modifications.
  • Independently manage a few large system(s)/projects(s) involving multiple functions
  • Identify and implement improvements with TOPS/Development Sciences impact.
  • Exercise judgment within broadly defined procedures and practices to identify and implement solutions.  Erroneous decisions or failure to achieve project goals may result in additional costs, serious delays to overall schedules or detrimental impact to product quality.
  • Participate in the annual revision of the Validation Master Plan for computer systems.
  • Enforce computer validation policies, processes and practices.
  • Provide QA oversight for system modifications, and system upgrades, including review and approval of changes and Validation Work Orders.
  • Maintain and develop process improvement metrics for QA Computer System Validation.
  • Perform and/or approve revalidation evaluations of qualified computer systems.
  • Assist in audits of computer system vendors as Subject Matter Expert.
  • Participate in inspection preparation and regulatory inspections, defending validation functions and studies related to computer systems.
  • Maintain current knowledge of industry standards and regulatory requirements for systems utilized by BioMarin for development, manufacturing, testing, release, clinical, and quality system activities related to BioMarin products.
  • Represent QA Validation in multidepartment and project team meetings
  • Present QA CSV project status at the Demand Management Committee and other interdepartmental meetings.
  • Strive toward constant improvement of validation systems in order to maintain compliance cGxP requirements for work performed.
  • Act independently to determine methods and procedures on new assignments.
  • Develop and present CSV training materials and deliver company wide
  • Oversee QA CSV Contractors as needed
  • Other duties as assigned.

This function will perform majority of work in an office setting, reviewing documents, participating in meetings, authoring documents.  This function may perform up to 80% of its functions at a computer terminal.


  • 10+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency of industry standards for computer system design, implementation, and validation.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to computer software (operating systems, software applications), computer and network hardware, and the associated regulatory expectations relating to them.
  • Experience in: project scope development, Request for Proposal development, contractor selection and contractor management.
  • Experience in large and small project implementation and budgeting.
  • Experience in participation in regulatory inspections, with experience in presenting or defending department functions in audits or regulatory inspections preferred, but not required
  • Network, LDAP, Domain, Database experience
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Access. 
  • Experience and proficiency with industry standard enterprise system applications (LIMS, SQL, MES, eDMS, ERP, CMMS, TrackWise, CMMS)
  • Practical understanding of GAMP and ERES standards and guidance.
  • Understanding and familiarity with FDA, European and ICH regulatory requirements, guidelines, and recommendations for validation expectations.  Understanding of regulatory guidelines for other countries a plus.
  • Experience in participating in regulatory inspections.
  • Experience in proficient report writing required.

Minimum BS in a technical discipline (computer science or biological science discipline preferred but not required).  Equivalent experience may be considered.


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