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Senior Validation Specialist

Reference:SGAILM-533799 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, Validation Specialist

Senior Validation Specialist

Life Science Recruitment are sourcing a Senior Validation Specialist for our client who are a leading global biologics manufacturer. The successful candidate will supervise a team of validation specialists in cold chain management whom are responsible for the review and approval of initial and continuing validation and qualification documentation for QA Validation (Thermal mapping of controlled temperature units (CTU’s)/warehouse and shipping validation). Responsible for ensuring that systems and processes are qualified and/or validated in accordance with regulatory requirements and company manufacturing standards. Salary will be dependant on experience with a ceiling in the region of 70 K EUR.

Roles & Responsibilities

  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
  • Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • Equipment preparation for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Reviews, edits and approves change control and SOPs.
  • Collaborates with functional departments to resolve issues.
  • May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department.
  • May train/advise less experienced Specialists and Technicians.
  • May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
  • Assesses quality system documentation for completeness and accuracy, and dispositions documentation within Regeneron SOPs.
  • Manages projects and prepares status reports.
    Interacts with Automation/Process Engineering for managing changes during qualification window.
  • Strong communication/presentation skills during internal/external audits.

Skills & Qualifications

  • BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; will substitute relevant experience for education.
  • Previous experience in supervising teams will be advantageous.

If you would like further Information you can contact the recruiter directly:

Simon Gillivan | Tel: +353 (0) 1 507 9258