Manufacturing Project Engineer

Title: Manufacturing Support Scientist/Engineer

Duration: 06 months contract

Location: Dublin 15

Russell Tobin collaborates with a prominent global biologics manufacturer, known for its dedication to enhancing the well-being of patients and staff. They hold the prestigious title of being one of Ireland's top large workplaces, and their commitment to impactful change is evident in their daily actions.

We are seeking to recruit a contract Manufacturing Support Scientist/Engineer, reporting into the Associate Director for new product introduction within the Manufacturing group. The Manufacturing Support Scientist/Engineer for New Products role is a key contributor and part of the pharmaceutical company team for sustainable biologics manufacturing capacity to the company network in Cruiserath, Dublin 15.

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 at company

• 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.

• 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.