Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Develops validation master plans, validation protocols, process flow diagrams, test cases, or standard operating procedures.

· Creates, populates, or maintains databases for tracking validation activities, test results, or validated systems.

· Designs validation study features, such as sampling, testing, or analytical methodologies.

· Draws samples of raw materials, or intermediate and finished products for validation testing.

· Follow the GMP and GDP practices during the execution of the protocols and preparing the Qualification documents.

· Perform studies to support necessary equipment and system PQ's and PPQs to assure compliance in all manufacturing and support areas, analyze data using appropriate statistical tools. · Prepares detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.

· Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental, validation and qualification protocols are met.

· Resolves testing problems by modifying testing methods or revising test objectives and standards.

· Perform viscosity tests on the product during coating solutions

· Initiate and participate as appropriate in associated change control requests, deviations, CAPAs and equipment acquisition documentation

· Generating and documenting effective corrective and preventative actions, to ensure all CAPAs

· Conducts audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.

· Implemented through GMP systems and provided timely updates to management on status of all GMP-related investigations; Monitoring of effectiveness of CAPAs.

· Directs validation activities, such as protocol creation or testing.

· Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.

· Procures or devises automated lab validation test stations or other test fixtures and equipment.

· Communicates with regulatory agencies regarding compliance documentation or validation results.

Bachelor's Degree is required in Pharmacy or Pharmaceutical Sciences

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