Our client, a top-tier biologics company is embarking on an exciting project and is seeking to bring aboard multiple CVQ Engineers on a contract basis.
Reporting to the CQV Lead for MFG6.2, 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 Facility and Equipment Qualification: Oversee the entire qualification process, from design to operational use, ensuring compliance with industry standards and regulations.
- Equipment Tracking and Schedule Management: Take charge of tracking equipment and managing schedules from design to system release during project phases.
- Safety and Compliance: Ensure the safety, effectiveness, and qualification of all equipment and processes, meeting industry standards and regulatory requirements.
- Authorship and Documentation: Create, review, approve, and execute testing protocols, reports, and policies.
- CQV Stewardship: Act as a steward for all company and site CQV and revalidation policies and procedures.
- Revalidation Oversight: Supervise the compliant execution and reporting of revalidation activities for process and support systems.
- Project Delivery and Troubleshooting: Take responsibility for project delivery, vendor inquiries, and the monitoring and troubleshooting of process systems.
- Project Team Participation: Be an active member of project teams, participating in all project phases, from conceptual design to system release.
- 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.
- A minimum of 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 programme.
- Experience of equipment vendor package ownership.
For further clarification or additional information contact Veronica Nkansah at HRM on +353 873449559 or please apply online with an updated CV.