Berkley Pharma & Life Science are currently seeking an Equipment Senior Scientist for our client, a leading pharmaceutical company based in Dublin.
Ref: 5040180
Role/Opportunity:
• Seeking an experienced Manufacturing Equipment specialist with a good understanding of mechanical and/or electrical engineering principles (applied to pharmaceutical systems preferred).
• The role involves establishing and managing the technical and cGMP status of manufacturing equipment in line with Good Manufacturing Practice (GMP) requirements within the Pilot Plant facility.
• Liaises closely with colleagues to ensure that practices are harmonised across the group on technology development and utilisation.
Key skills and experience include:
• Minimum of a third level qualification in Chemistry or related discipline
• At least 5 years relevant technical experience in a highly regulated environment (IMB/FDA)
• An understanding of Lean Principles/Operational Excellence tools and “hands on” implementation of same in a pharmaceutical environment
• Strong organisational skills with the ability to multitask and prioritise workload in a fast moving environment
• Excellent verbal, written and interpersonal communication skills with the ability to interact effectively at all levels within the organisation
• Thorough practical understanding of equipment qualification processes applied to GMP manufacturing equipment and facilities and show evidence of commissioning, qualification and ongoing validation of complex and bespoke manufacturing technology in a GMP environment.
• A contemporary understanding of cGMP regulations/guidance in relation to all aspects of qualification of processes and equipment and manufacturing technology development
• Experience of managing the interface with Engineering service providers and third party vendors providing maintenance and engineering support for R&D
• Experience with standard software packages and ability to understand and use HMI controller systems and other enabling information technology systems is also required.
Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia
For more information go to http://www.berkley-group.com
To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sinéad Hawes on +353 (0)1 8724667 or send your CV to science@berkley-group.com