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Job ID :
64267BR
Location :
Australia - Brisbane
:
Job Description

Validation engineer Job Ad

Summary

Serves as subject matter expert for the Validation department. Responsible for validation deliverables for projects as well as participation as an interactive member on Project Teams as a representative of the validation department. Writes and executes commissioning and validation documents on equipment, instruments, facilities, utilities, processes and computer systems, utilizing the lifecycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Participation on various project teams will be required.

Key Requirements

  • Develop commissioning and qualification lifecycle documentation as well as writing and revising SOPs as necessary.
  • Responsible for protocol execution requiring interface and coordination with Validation Contractor personnel, Manufacturing, QA, QC, Facilities, Metrology and Engineering departments as part of a project team to assure expeditious and accurate completion per agreed upon project plan.
  • Summarize and evaluate protocol data involving resolution of discrepancies and exceptions as required for completion of validation summary reports.
  • Perform periodic reviews or re-qualifications to maintain validation status of equipment, facilities, utilities and computer systems as defined by approved validation SOPs.
  • Proficient with computer (MS Office). Working knowledge of controlled documentation and data systems.
  • Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make logical decisions based on guidance from management.
  • Knowledgeable in cGMP regulations.
  • Demonstrated ability to work on multiple projects.
  • Good organizational skills and problem solving abilities.
  • Computer System Validation experience desired but not required (21CFR Part 11, GAMP 5)

    Qualifications

    EDUCATION AND QUALIFICATIONS:

  • Bachelor’s Degree in Engineering, Life Sciences or Computer Science with 5+ years of experience in pharmaceutical validation, or equivalent experience.
  • Subject matter expert in one or more of the following areas: Validation of equipment, automated systems, instruments, facilities, utilities, processes and computer systems (including 21 CFR Part 11 compliance).
  • In depth knowledge of cGMP regulations.
  • Demonstrated ability to work on multiple projects.
  • Excellent organizational skills and problem solving abilities.

    Physical Demands/Factors

  • Ability to aseptically gown and/or sterile gown as needed
  • Ability to work within environmental clean rooms
  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
  • While performing the duties of this job, the employee is required to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
  • Is regularly required to talk and hear. The employee frequently is required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.



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