Manufacturing Support Scientist New

2 days ago


Dublin, Ireland CPL Full time

Manufacturing Support Scientist/Engineer - 6 Month Contract (61163)

Responsibilities

• 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, CAPA’s, investigations, improvement projects and operational safety.

• Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.

Qualifications and Experience

• 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.



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