Validation Lead

Confidential Company  •  Morgantown, WV
Salary depends on experience
Posted on 03/02/18 by Cynet Sytems
Confidential Company
Morgantown, WV
IT Consulting/Services
Salary depends on experience
Posted on 03/02/18 Cynet Sytems

??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.

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