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Senior CQV Engineer (CSV Focussed)
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
The CQV Engineer is responsible for ensuring that all manufacturing process systems perform and operate as per their design and validated state. Ensure that all systems conform to relevant regulatory requirements as well as company specifications and standards. 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.
- 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.
- 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 / lead technical transfer activities and associated PPQ studies.
- Responsible for project delivery, vendor enquires and the troubleshooting and monitoring of
- 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.
- Responsible for initiation and completion of deviations, CAPAs, and change controls for
process systems including investigations relating to equipment or process performance.
- Support the introduction of new process materials and components to the site.
- 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.
- Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
- Minimum of 5 years’ experience working in a Biologics or similar GMP environment as
part of an engineering, technical services or operations function.
- Technical / engineering knowledge of Upstream and / or Downstream biologics systems and
- Knowledge and experience with facility start-up projects (brown field or green field).
- Experienced in the execution of commissioning and qualification of process equipment (e.g.
bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
- Experience in troubleshooting and providing technical and engineering solutions for GMP
manufacturing operations and equipment in a biologics processing environment.
- Knowledge / experience in the qualification of GMP utilities and associated systems and
processes (e.g. WFI, Clean Steam, CIP, SIP).
- Experience operating in a fully automated Delta V facility.
- Experience in establishing the procedures, policies and masterplans that define a CQV and
- Experience of equipment vendor package ownership and system design coordination.
- A postgraduate qualification in an engineering or scientific discipline
- A qualification in project management
- Experience of temperature mapping e.g. vessel SIP, Autoclaves, cold rooms, fridges and
- Experience executing cleaning validation studies e.g. spray ball coverage assessments, hold
time studies and swab sampling.
- Experience executing PPQ related studies e.g. process hold studies, chromatography resin
and UF/DF membrane management studies.