Validation Engineer Job

· Hands on performing temperature mapping studies for Freezers, Refrigerators, C02 Incubators, Cryo pods and warehouse environments to ensure compliance with regulatory standards (FDA, GMP, GLP ISO)

· Utilized Data Loggers, Thermocouples using Ellab and Kaye Validators to monitor and record the Study data.

· Lead for QC Lab activities of CSV Systems qualification like Microscopes, Endosafes, FTIR’s and validation for Autoclaves and Dry Heat Ovens in Support of FDA commitments.

· Development of typical Qualification deliverables, including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Summary Reports.

· Support qualification of the Quality Control equipment and system

· Maintain change control for all validated processing equipment and investigate deviations related to equipment failures as required.

· Prepare equipment/systems for qualification studies and executes according to approved protocols and SOPs

· Develop SOPs and VMPs for process.

· Collaborate with Quality Assurance, Maintenance and Operation team to address Temperature Deviations and implement corrective actions.

· Gather current knowledge from QA/QC, regulatory, Audit findings, periodicals and/or appropriate training programs.

· Review the forms related to Process of start of the system Qualification.

· Maintain change control for all validated processing equipment and investigate deviations related to equipment failures as required.

· Perform Root Cause Analysis Mechanisms. Identify the issue and define optimistic solution

· Critical Technical Production Issues Resolution: Root Cause Analysis, Collaboration with various technical teams, Strong Understanding of business flows and integrated up stream & downstream applications.

· Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

· Prepare Deviation reports for each failed studies or any other deviating procedures

· Work proactively to maintain the highest level of compliance in all areas of responsibility.

· Plan and manage equipment qualification including execution support for IQ, OQ, PQ and Requalification.

· Maintain current knowledge in the areas of compliance, validation and other regulatory issues that may impact the business.

· Interface extensively with the QC/QA, Production and Maintenance departments to identify projects and problems requiring validation support

· Plan and manage scheduled preventative maintenance.

· Responsible for development and improvement of Validation Master Plan.

· Supporting Vendor Qualification activity by following the site procedures

· Perform Acceptance Testing execution of all equipment alongside vendors, including system walk downs and input/outputs verification.

· Alarm testing and functional testing ensuring proper installation and turnover.

· Responsible for generation and execution of Qualification/Validation documents which includes commissioning protocols, plans, URS/SRS, IOQs, CDs and PQs.

Bachelor's Degree is required in Pharmacy or Pharmaceuticals Engineering or Pharmaceutical Sciences.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave