QA Validation Engineer Job

QA Validation Engineer to perform the following duties :

• Work under the close direction and guidance of our Engineering Manager and our QA Manager to analyze and test technical/ validation data and ensure continued quality compliance of technologically advanced scientific equipment, utilities, and engineering systems in our facility;
• Conduct research as directed and draft maintenance and engineering department Standard Operating Procedures for review and approval by our Engineering Manager;
• Work in a group setting under the guidance of our Engineering Manager to perform equipment qualifications including preparing/reviewing of installation (IQ), operation (OQ) and performance (PQ) qualification documents/protocols for manufacturing/packaging equipment in line with cGMP requirements. Draft technical reports as instructed for review and approval by our QA Manager;
• Follow guidelines from QA team & Engineering Manager to prepare/ review/test qualification protocols of utility systems in the plant, identify deviations and develop mitigation solutions & perform requalification under close supervision. Will create Preventive Maintenance/ Calibration Schedules and records of equipment, monitoring and measuring devices etc. for engineering manager’s review, correction and approval;
• Prepare validation documentation for process validation, cleaning validation while developing process study protocols and writing summary reports after completing validation tests for QA and engineering managers review, correction and approval;
• Work under the close guidance of our engineering manager to assist QA team in qualification of external service provider that executes various maintenance, calibrations, and qualification activities in the facility;
• Coordinate with internal teams to assist Engineering Manager identify user requirement specification by preparing technical design documents as instructed. Will follow established guidelines and interpret equipment capacity and functionalities from design document and equipment manual that ensures procurement of correct equipment for the intended operation;
• Work under close supervision of our Engineering Manager and QA Manager to coordinate internal audits and prepare audit reports while monitoring effectiveness of corrective and preventive actions against non-conformities;
• Will review change controls related to Process, Equipment and deviations as per Standard operating procedures. Will prepare detailed technical reports following engineering principles for review and approval by Engineering Manager;
• Follow instructions and prepare/archive Quality Assurance documents as per in-house document/record retention procedures and established guidelines;
• Work in a group setting with other engineers and QA team members to assist in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements while assisting with corrective/preventive actions; and
• Approximately 85% of the time will be spent in analyzing validation data, drafting SOPs, validating/calibrating equipment, performing qualification activities, developing process study protocols, conducting change control activities, preparing validation protocols/documents etc. – all under the close supervision and guidance from our Engineering Manager and our QA Manager. Approximately 15% of the time will be spent in liaising with internal teams, drafting validation/technical reports, assisting managers with vendor qualifications, coordinating/drafting audit reports etc.

Bachelor’s degree is required in Mechanical Engineering or Engineering Management or Industrial Management