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Validation Specialist

Ontario, ON

PharmEng Technology is currently seeking a Validation Specialist in Ontario, Canada. This position is available immediately conditional of a successful interview.


Job Description:
  • Manufacturing Process Validation
  • Production Equipment Validation
  • Mixing Validation
  • Cleaning Validation
  • Sterile Process Validation
  • Responsible for developing Installation and Operational Verification (IOV) protocol templates, writing and executing IOV protocols, deviation resolution and development of Final Reports in accordance with the requirements of this document and associated scope documents. Authoring and execution of Performance Qualification (PQ) protocols will also be in scope for certain equipment and systems
  • To developed protocols are indicative of the system environment following SOP, system specifications, and RVQSARs, IOV and PQ documents.
  • 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
  • Include reviewing existing documentation from the library, as needed.  Manager will need to update Equipment Verification Tracker with current document progress, weekly
  • Authoring and executing IOV protocols for new equipment and systems for the Train 2 Commercialization Project. An equipment verification matrix/family approach is acceptable for operational verification activities when clearly defined and justified in the approved verification protocols.
 
Job Requirements:  
  • B.Sc. degree or related professional experience within the Biopharmaceutical Industry
  • 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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