Description:
This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the biopharmaceutical and related industry sectors, from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally.
Recently a significant investment has been undertaken to build a new cell culture green-field manufacturing site, which will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site and employs in the region of 500 staff.
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 Role
This is a minimum one year contract. Responsibilities will include:
- 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 and 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 systems.
- 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.
- 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 programme.
- 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.
- Will act as a role model for the Engineering function and also the wider organisation in adherence to the corporate core values and culture.
The Person
- Previous DeltaV experience is a must.
- Significant experience of relevant process engineering equipment, processes and systems in a highly regulated manufacturing environment.
- 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.
- Qualifications - B.Eng or B.Sc in chemical / process engineering or relevant science discipline is required