??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
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.
- 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.