Process Engineering Specialists

About Process Engineering Specialists

Roles & Responsibilities We are looking for Validation Engineers with 3+ years’ experience in the pharmaceutical industry for permanent/contract opportunities with our company: Key Responsibilities: Responsible for the execution of the validation program in following the required DQ, IQ, OQ, PPQ and requalification activities (production equipment). Coordinates all testing activities supporting validation and calibration activities for the site. Coordinates technology and product transfer activities as required and provide technical assessments on change controls, deviations, and investigations. Assist in development of validation strategies for the entire process including risk assessment and test method validation. Assist in all areas of commissioning, qualification validation and calibration in alignment with FDA, EU and ISO standards. Lead and manage complex validation and technical projects using Flawless Project Execution (FPX) methodologies. Assists superior on CAPA management process and NC investigation and QA Incoming in Localization Project. Represent Advanced Engineering during Validation Review Board (VRB). Prepare validation deliverables document such as Installation Qualification Protocol (IQ, OQ, and PQ) and Validation Summary Report (IQR, OQR, and PQR). Provide brief training before validation activities to the executor and reviewer. Coordinate and provide guidance to the executor during IQ, OQ and PQ execution. Engage with different department to obtain evidences document. Prepare summary report for IQR, OQR and PQR. Upload validation documents into Agile and follow-up to the closure. Update validation status from time to time. The right candidates must have sufficient experience and knowledge in the pharmaceutical and biopharmaceutical industry: Degree from engineering, biotech, resource biotechnology or related fields Minimum 3+ years’ relevant execution experience in Commissioning, Qualification, Validation and Risk Assessment within the pharmaceutical industry Must be a self-starter and highly motivated Be able to function successfully in high pressure fast moving multi-discipline / Multi-cultural team project environments. Strong interpersonal and communication skills both verbal and written are required for the execution of this role.

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Company Type: Private

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