This leading global biologics organisation provides comprehensive integrated and customisable services to the biopharmaceutical and related industry sectors from contract development services to contract manufacturing services. Recently, this business has announced expansions into regions such as the U.S and Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site. Once built, this manufacturing site will be the largest single-use biologics manufacturing plant globally and will employ around 400 staff. 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. With this expansion, an exciting opportunity has arisen for a Calibration SME to join the organisation at the start-up phase in leading this business through construction and into manufacturing.
The Calibration SME is responsible for the implementation of an instrument reliability program with a view to optimize the instrument maintenance/calibration program, identify measurement system improvements, and contribute to operational improvement initiatives on an ongoing basis, for process utility and QC laboratory instrumentation. In this role, you will be responsible for the operational integrity of the site calibration program through ensuring adherence to site, corporate and regulatory requirements, safety regulations and acting as point of contact during all internal and external audits. In addition, you will:
- Act as SME for plant instrumentation and test equipment.
- Be responsible for ensuring the integrity of integration into site automation systems and establishing associated maintenance/calibration programs for the measurement loops.
- Develop, maintain and ensure adherence to Cals standards and specifications.
- Provide guidance on changes to measurement systems/instrumentation.
- Co-ordinate contract Calibration resources to provide support to sustain operations.
The Calibration SME will have a minimum of 7 years' experience within high volume manufacturing within Biologics/Pharma sectors.
As the Calibration SME, you will also have demonstrated expertise within the following areas:
- A background in or experience with instrumentation and control systems (commissioning and sustaining operations).
- Certification to a minimum of Method 1 or Six Sigma Yellow Belt level.
- Strong analytical skills in gathering data from operations groups, defining work problems.
- An ability to influence and affect change within organizations without direct line management supervision.
This is a permanent position and comes with an excellent package along with superb working conditions.
To discover more about this opportunity, apply now or contact James Colbert at HRM on +353 1 6321840 for a confidential discussion.