Emerson are the predominant supplier of automation systems to the biotechnology manufacturing sector in Ireland. Based in Ireland for over 15 years, the company has market leading automation and MES systems as well as associated hardware and field instrumentation. Emerson are looking to significantly increase their team to meet the growth in the sector in Ireland. With offices in both Cork and Dublin, these roles will give opportunities to work on the process automation of major pharma and biotech projects, implementing new technologies and developing industry leading manufacturing information systems. The Irish offices provides automation solutions to the Life Science sector across Europe, with Ireland being the center of excellence for the company’s flagship MES product.
With a large installed base of automation systems in Ireland across most of Irelands biotech manufactures, Emerson have significant opportunities available in both on site and office based roles. This role will involve significant interfacing with the client, modelling the process, developing functional specifications and managing the automation delivery of individual process areas.
Successful candidates will have the opportunity to advance their career using Emerson’s talent management programme with significant training on both automation and MES systems as well as industry trends, new technologies and exposure to pharma and biotech processes.
This role has two elements, both developing and enforcing the Quality Systems for projects and taking the Computer Systems Validation role for Life Science projects. This project experience gives the necessary understanding to deliver appropriate Quality Systems. Both roles require someone who is prepared to be the Quality ‘voice’, and who will champion quality on projects as well as within the department.
REQUIRED QUALIFICATIONS AND EXPERIENCE
– Technical degree or equivalent with at least 10 years experience with focus on the life-science industry and a proven track record.
– Proven experience with IT Quality Management and Computerized Systems Validation (GMP, 21CFR Part 11, GAMP) together with PCS/MES application implementation and deployment in the regulated pharmaceutical industry including awareness of customers’ responsibilities
– Good knowledge of European and International major pharmaceutical regulatory requirements (FDA, EMEA, ICH)
– Trained in ISO 9001 with auditor training and relevant experience
– Ability to influence the culture of a project team or department to adopt and maintain good quality standards.
– Experience in Quality Management and Quality Systems development.
– Proven experience and personal credibility in front of customers and colleagues is essential.
– Basic knowledge of project management
– Ability to deliver training.
– Member of ISPE, with involvement in Communities of Practice to ensure current knowledge.
For more information on this role please contact Eoin on 021-4777329 or apply directly through this advert.