Manufacturing Support Specialist
1 day ago
PE Global is currently recruiting for a Manufacturing Support Scientist on behalf of our client based in North Dublin: Full Time 6 Month Contract Responsibilities will include (but not limited to): Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing Represent the Manufacturing at meeting to ensure the end user requirements are represented Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches. Identify process improvement projects for New Product Introduction and support projects to completion. Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understood Write process impact assessments to support new product introduction Provide SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures and documentation. Provide training to BPAs on new procedures. Support external and internal audits. Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction . Work to implement a Right-First Time Culture and provide leadership in the use of OE principles. Support the disposition process when required Carry out organizational activities such as purchasing & co-coordinating communication information. Own & drive change controls, CAPAs, investigations, improvement projects and operational safety. Minimize human error and work with operations to remove sources of error. Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team. Support sustaining operations when required to ensure product supply Develop strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance. Support and implement new technology solutions such as Single-Use technology. Qualifications and Experience required: Ability to demonstrate proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. In addition, must have proven success working in a team environment, as well as strong leadership & influencing skills, with flexibility to react to changing business needs. Problem solving and project management ability, as well as lean manufacturing experience is essential. Currently completing a Bachelors/Masters in Science, Engineering, or a related subject. In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation. Proven ability to support the closeout of complex technical investigations. Strong working knowledge of systems such as Delta V, MES Syncade and SAP. Excellent presentation skills. Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: biologics manufacturing new product introduction
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