Overview
Validation Engineer
is responsible for the planning and execution of the qualification activities associated with all facility, utilities, equipment and instruments and process, cleaning and shipping validations in compliance with all relevant cGMP regulations, company policies and procedures.
Responsibilities
Execute qualification and validation activities for life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state.
Author, review, execution and approval of testing protocols and reports.
Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
Will be flexible to take on additional tasks and responsibilities as requested.
Will act as a role model for the Validation function and also the wider organization in adherence to the MSD corporate core values.
Basic Qualifications
A bachelor's degree qualification in an engineering or science discipline.
A minimum of 3 - 5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function.
Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.).
Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
Experience of equipment vendor package ownership and system design coordination.
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