CQV Engineer Upstream & Downstream

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CQV Engineer Upstream & Downstream

Reporting to the CQV Lead, this role will be involved in the design and CQV activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing CQV activities during sustaining operations.  The CQV Engineer is responsible for ensuring that all manufacturing process systems perform and operate as per their design and validated state.  The CQV Engineer ensures that all systems, conform to relevant regulatory requirements as well as company specifications and standards.  This role will support the implementation of both manufacturing process and utility/infrastructure changes including new system introductions and existing system improvements and enhancements.  This includes design, vendor selection, change control, project management and CQV activities.

 

Essential Duties and Responsibilities
·       Manage the facility and equipment qualification – from design through to operational use.

·       During the project phase, be responsible for equipment tracking and managing the schedule from design through to system release to operations.

·       Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.

·       Responsible for project delivery, vendor enquires and the troubleshooting and monitoring of process systems.

·       Participate on project teams through all phases of projects – conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.

·       Authorship, review, approval and execution of testing protocols, reports, and policies.

·       Act as steward for all company and site CQV and revalidation policies and procedures.

·       Oversee the compliant execution and reporting of all revalidation activities for process and support systems.

·       Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment or process performance.

·       Support / lead the resolution of significant production related deviations and events.

·       Ensure that new process systems are included in the maintenance and calibration program.

·       Project management of process system upgrades and modifications.

·       Perform additional duties at the request of the direct manager.

·       Perform all duties in accordance with GMP requirements, SOPs and controlled documents

·       Will be flexible to take on additional tasks and responsibilities at the discretion of the CQV Associate Director

Technical Competencies

·       Ideally, CQV experience in a ‘greenfield’ or ‘brownfield’ context of similar size and scale.

·       Significant experience of relevant process engineering equipment, processes and systems in a highly regulated manufacturing environment.

·       Experience in troubleshooting Delta V driven systems is essential

·       Demonstrable ability to influence key stakeholders, build strong relationships and execute to the CQV business strategy.

 

Requirements

·       B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required

·       Experience of temperature mapping e.g. vessel SIP, Autoclaves, cold rooms, fridges and freezers.

·       2 years+’ Experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function.

·       Experienced in the execution of commissioning and qualification of process equipment (e.g. bioreactors and process vessels, chromatography, autoclaves, parts washers) and/or CIP skids

·       Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.

·       Experience operating in a fully automated Delta V facility.

·       Experience in establishing the procedures, policies and masterplans that define a CQV and revalidation program.

·       Technical / engineering knowledge of Upstream and / or Downstream biologics systems and processes.

·       Knowledge / experience in the qualification of GMP utilities and associated systems and processes (e.g. WFI, Clean Steam, CIP, SIP) is desirable