Validation Specialist

Level Years of Experience
Junior 2-5
Intermediate 5-8
Senior 10+






 
PharmEng Technology is currently seeking multiple Validation Specialist Positions in Sanford, North Carolina. The positions are available immediately conditional of a successful interview.

Job Description:
  • 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 formatting
  • 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 all documents (IOVs, some PQs, deviations, Final Reports, amendments, re-testes, etc.)
  • Develop Equipment Templates based off a current project template
  • Develop Final Reports of all IOVs and some PQs, including the packages containing all supporting data that are submitted to the library
  • Document all deviations (including Protocoll Non-Conformance Reports (PNRs) requiring QA approval)
  • Routing documents through PDOCs for review or approval
  • Protocol Development for IQ/OQ/PQ documents
  • Attend project meetings as required
  • Experience with various quality system processes
  • Plan and conduct work requiring judgment in independent evaluation, selection, and substantial adaptation/modification of standard techniques, procedures, and criteria
  • CIP and SIP Operational execution of circuit confirmation will be performed by process/ manufacturing personnel.
  • HVAC PQ is will be written and executed, Sample collection for WFI and Clean Steam PQs.
  • Manage the development and execution of Verification protocol, deviations, PNRs, amendments, retests and final reports
  • 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
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
 
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