Manufacturing Technologist

This is what you will do:

The Manufacturing Technologist’s main area of responsibility is the technical ownership of upstream / downstream unit operations and provide real time technical leadership on any process or equipment issues in line with business strategies and objectives.

The Manufacturing Technologist is responsible for the successful execution of projects and improvements identified as part of the Athlone facility priority list. These are in several categories, including: new process / equipment introduction/remediation/optimisation (CAPEX & OPEX), process innovation, automation, product transfers, process feature optimisation & enhancements, new material introduction, equipment qualification, continuous improvement /cost reduction in facility and process operation.

You will be responsible for:

• Manufacturing Technologists are responsible for Manufacturing Support to the BDS operations at Athlone during new product introductions.
• They provide end user operations requirements input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams. 
• Requires significant subject matter expertise and provides technical leadership, leading complex projects relating to improvements and investigations within the BDS operations function.
• Be a mentor to the rest of the NPI team and provide direction  for complex projects.
• Leader and provider of expert technical and documentation support to investigations, CAPA’s, change controls, training and improvement projects to ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in the relevant health authority submissions, cGMPs and local Health and Safety requirements.
• Lead role developing Operations procedures, batch records (electronic or paper as required), other documentation and provide technical training to the Operations teams.
• Take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
• Successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.
• Develop and maintain strong and effective relationships with partners at Athlone including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources and Finance. They lead and contribute to best practice sharing with manufacturing and technical colleagues at other Alexion facilities and across the industry.

You will need to have:

• A minimum of 3- 5 years’ experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry.
• Extensive knowledge of  biological manufacturing processes
• Significant experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations.
• Experience of capacity expansion and new product introduction project work is essential and experience of a green field start-up is desirable
• Experience in investigating complex manufacturing investigations, CAPA’s and Change Controls.
• Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation.
• Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise.

• Good Presenting and Training Skills
• Good Technical writing skills
• Excellent communications and decision-making skills
• Min Green Belt in Lean six sigma
• Proven ability to work well as part of a team & on own with minimum supervision
• Proven leadership skills.
• Other duties as required.

We would prefer for you to have:

• Undergraduate degree in science or engineering or equivalent is required.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.