Validation Lead


Morgantown, WV

Industry: IT Consulting/Services


Not Specified years

Posted 259 days ago

  by    Cynet Sytems

This job is no longer available.

??We are looking for Validation Lead for our client in Morgantown, WV

Job Title: Validation Lead

Job Location: Morgantown, WV

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

Job Description:

Validation Lead Essential Duties and Responsibilities:

  • Prioritize and coordinate the daily activities of the Validation Engineers and Technicians/Validation contractors.
  • Develop validation protocols to support the qualification/validation of equipment, processes and facilities (, OQ and PQ protocols, Operational SOPs Change Controls, User/Functional/Design Specifications, etc).
  • Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment, utilities as applicable) and other related systems in a FDA regulated environment.
  • Initiate and execute Corrective and Preventative Actions (CAPA) as required and / or contributing to/supporting CAPAs as needed to resolve deviations resulting from qualification studies
  • Update and maintain Validation Master Plans, Validation Plans, Validation Protocols, Qualification Program SOPs, forms, records to meet cGMPs and federal regulatory requirements.
  • Experience/understanding of cGMP, ICH Q9 Quality Risk Management is desired.

Education/ Experience:

  • Position requires advanced industry experience in cGMPs/ Lab. Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
  • Strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry.
  • Excellent verbal and written communication skills required
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control is required.
  • Experience with validation aspects of Lab equipment qualification, redesign/retrofit, and expansion is desired.