Sr. Validation Consultant

PharmEng Technology is currently seeking a Senior Validation Specialist in Tennessee. 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 findings
  • 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.
  • Complete, review, and/or approve risk assessments for instruments, equipment, processes, and products.
  • Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis.
  • Prepare and/or evaluate change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state, including definition of appropriate requirements in change control documents, completion of identified action, and preparation of applicable reports and data packages.
  • Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and document the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions.
  • May supervise a few engineers or specialists and/or technicians on project basis.

Job Requirements:  
  • B.Sc. degree and a minimum of 5-7 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.
  • Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.
  • Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
  • Certifications in Project Management & Demonstrated experience in personnel management.
  • Experience at working both independently and in a team oriented, collaborative environment is essential.
  • Can conform to shifting priorities, demand and timelines through analytical and problem-solving capabilities.
  • Reacts to project adjustments and alterations promptly and efficiently.
  • Ability to read communication styles of team members and contractors who come from a broad spectrum of disciplines.
 
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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