Sr. Validation Engineer Position Available In Hillsborough, Florida
Tallo's Job Summary: Sr. Validation Engineer position available at ND Global Consulting Services, Inc. in Tampa, FL. Requires a Master's degree in Engineering Management, Mechanical Engineering, or Process Engineering, along with 1 year of experience in validation engineering. Responsibilities include analyzing validation deliverables, ensuring compliance with regulatory standards, conducting testing activities, and developing validation plans. Benefits include health insurance and PTO.
Job Description
Sr. Validation Engineer needed w/Masters degree or Foreign Equivalent in Engineering Management or Mechanical Engineering or Process Engineering and one (1) year experience as Sr. Validation Engineer or Validation/Packaging Engineer performing following job duties:
Analyze and review key validation deliverables, such as validation plans, risk assessments and validation summary reports, ensuring full compliance with 21 CFR Part 11, GAMP 5 and GMP FDA regulations.
Ensure adherence to regulatory and industry standards throughout the project lifecycle. Review, approve and execute key validation documents, including User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
Investigate validation deviations, implement Corrective and Preventive Actions (CAPA), perform comprehensive risk assessments and maintain the Requirement Traceability Matrix (RTM) to ensure compliance with regulatory standards and internal procedures.
Prepare, execute and document Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities to ensure the operational readiness and regulatory compliance of equipment in accordance with the validation lifecycle.
Responsible for development of the Validation Master Plan (VMP) for the entire packaging line project, creating a structured and comprehensive framework to guide validation activities throughout the project lifecycle.
Conducted Qualification Review Program (QRP) activities, thoroughly reviewing and assessing change controls, operational manuals, SOPs, calibration certificates and corrective and preventive maintenance records for manufacturing equipment and utilities listed in the VMP.Led the review of packaging validation protocols, batch records, specifications and bills of materials.
Generate and execute decommissioning protocols for assembly and packing equipment, contributing to the closure of equipment qualification processes by preparing comprehensive reports to ensure proper documentation and regulatory closure.
Job Locations:
Tampa,FL or unanticipated client sites within the U.S.Must be available to travel and relocate to unanticipated client sites for temporary projects.
Benefits:
Health Insurance and PTO.
Mail Resumes to:
ND Global Consulting Services, Inc.15310 Amberly Drive, Suite 250, Tampa, FL 33647
