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Validation Specialists

FL, FL
Validation Specialists (Validation and Qualification)
PharmEng Technology is currently seeking multiple Validation Specialists for roles in FL.  The positions are available immediately conditional of a successful interview.

Job Description:
  • Provide direct execution support for C&V activities.
  • Author and execute qualification documents such as Validation Plans, Risk Assessments, Qualification Plans, Installation Qualification Protocols, Installation Qualification Protocols, Operations Qualification Protocols, Qualification Summary Reports, Trace Matrices, URS and Specifications.
  • Verification protocols will be written and tested so as to enforce user & equipment safety at all times.
  • Verification IOV and PQ testing must be cGMP compliant. The ultimate goal of Verification is to verify end product conformance to regulatory requirements and critical aspects.
  • Develop Final Reports of all IOQs and some PQs, including the packages containing all supporting data that are submitted to the library.
  • Document all deviations (including Protocol Non-Conformance Reports (PNRs) requiring QA approval).
  • Routing documents for review or approval.
  • Attend project meetings as required.
  • Experience with various building systems and support equipment.
 
Job Requirements:  
  • B.Sc. degree or related professional experience within the Biopharmaceutical Industry.
  • 3-10 years previous validation experience required.
  • Developmental experience within a specific area of validation or engineering. Knowledge of current validation/engineering technologies and maintain a solid proficiency of computer skills. 
  • Candidate will be capable of working independently while on assignment, as well interacting with the client in providing responses to project progress and updates on assignment progress. 
  • Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.
  • Position requires quality and scientific writing skills and capable of working to project timelines.
  • Excellent verbal, written and interpersonal communication skills.
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