Desired Skills: tech transfer,NPI,quality
The role:
PE Global is currently recruiting for a Tech Transfer Specialist on behalf of a leading pharmaceutical company based in Meath. This is an initial 11-month contract role.
Job Purpose:
- An amazing opportunity has arisen for a Specialist, within the Technology Transfer Delivery Team, at our new state of the art, single use, multi-product facility in Dunboyne.
- The Technology Transfer Delivery group will work closely with external stakeholders as well as internal partners such as Process Engineering, Quality, Operations, Process Automation and Development to deliver seamless NPI to our multi-product facility.
- The successful candidate would be a responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy. They will also act as a Change Champion within the organization and site, to bring about new products, digitization, and ways of working
Responsibilities:
- Collaborate with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.
- Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
- Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
- Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
- Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
- Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
- Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
Education and Experience:
- Minimum of 3 years of work experience in the pharmaceutical or biotech industry
- Bachelor’s degree in Engineering, Biotechnology, Chemistry, or related field.
- Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
- Understanding of the principles and activities of New Product Introduction NPI/Tech Transfer
- Familiarity with the use of Automation systems in a manufacturing Process such as DeltaV, MES, eVal as well as business tools such as Power Project and Power BI.
- Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
- Validation experience including validation documentation generation and execution
- Competent in analyzing complex situations and showing practical problem-solving capabilities
- Ability to work as part of a team and on own initiative in a constructive manner.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Contract 
Dunboyne, County Meath, Ireland 
42052604 
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