Senior Validation Specialist

 
Senior Validation Specialist
 
 
PharmEng Technology is currently seeking a Senior Validation Specialist in Georgia, USA. The position is available immediately conditional of a successful interview.

Job Description:
  • Develop and revising of Facility/Validation/Quality master plans
  • Performing system and document GAP analysis
  • Identifying and developing solutions to correct GAP finding
  • 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.
  • Devise new solutions to problems encountered.
  • May serve as the lead validation person on small to medium size projects. 
  • Conducts internal training in at least one area of expertise.
  • Recognizes and helps mitigate project risk.
  • Finds innovative, effective uses of technology applications for validation. Independently performs most assignments with instruction only regarding general expected results.
  • Receives technical guidance for unusual or complex problems and supervisory approval of proposed project plans.
  • May supervise a few engineers or specialists and/or technicians on project basis.

Job Requirements:  
  • B.Sc. degree and a minimum of 7-10 years of experience within the Biopharmaceutical Industry
  • 5 years 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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