Validation Engineer

Validation Engineer job Overview:

Validation engineer is a qualified engineer who manages, inspects, calibrates, evaluates, and modifies the instrumentation, equipment, mechanics, and procedures used to manufacture various products. They ensure all systems are running correctly and efficiently to produce high-quality products.

Validation Engineer is needed to perform the following duties:

Test Method Development/Validation:

· Perform various complex characterization studies for the test requirements which align the design input requirements.

· Identify the product failures by establishing test standards, test methods, test environments and identifying the root cause by analyzing and evaluating the findings and failures. Lead investigation for NC and CPA.

· Create, develop, and document critical test fixtures, including selection of appropriate measurement instrumentation, and mechanical design. All the phases from design phase to implementation of test fixtures must be documented appropriately, based on the level of testing to be performed according to FDA and ISO 13485 regulations.

· Create and continuously improve Test Methods for different processes to ensure that consistent implementation of internal requirements and external regulations and standards are met.

· Perform functional testing, ensure all systems are running in accordance with specifications and operate within regulations to ensure the production of quality products.

· Executes validation studies which include protocol preparation, scheduling, protocol execution, and final report preparation.

· Support ISO 13485, FDA, and customer compliance requirements by maintaining quality system documentation and ensuring adherence to applicable regulatory standards.

· Responsible for overseeing calibration activities to ensure equipment remains accurate, compliant and within established calibration requirements.

Process Validation (IQ, OQ and PQ Protocols and Reports) for Existing and New Processes:

· Collaborate with cross functional teams to Develop Typical Qualification deliverables, including Functional and Design Specifications, Test Protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for Class III medical device (cardiac arrhythmias) products following Good Documentation Practices (GDP).

· Collaborate independently across different departments to ensure all quality aspects of validation and qualification activities including process validation, equipment and/or utility/facility qualification, computer validation, Installation Qualifications (IQ), Operational Qualifications(OQ), and Performance Qualifications (PQ) are per DWI requirements

Determine Process Capability/Stability and Test Method Repeatability and Reproducibility using Statistical Method:

· Perform Design of Experiments (DOE) and identify various critical process parameters with the use of statistical tools such as interaction plot, optimization methods, and process capability studies.

· Conduct Gage R&R studies as a part of Test Method Validations using Minitab and analyze results to identify Precision to Tolerance and Study Variation are within acceptance.

· CMM Programming for First and Final inspections.

Master Validation Protocols/Report:

· Create and Review Master Validation Plan (MVP) for different product families/ processes and make sure the entire Master Validation Report (MVR) is completely updated after remediation activities.

Engineering Change Order Approvals, Equipment Specs Creation/ Update:

· Create engineering change orders (ECO’s) for new test methods, Qualifications, drawings, revising risk documents etc. using Teamcenter (PLM Software) prior to implementation

Education:

Bachelor's Degree is required in Energy Management or Mechanical Engineering or Process Engineering