Manufacturing Technologist

Introduction to role:

Are you ready to make a difference in the world of biopharmaceuticals? As a Manufacturing Technologist, you'll be at the forefront of supporting complex, life-changing biological products. Your role will involve new product introductions, process monitoring, investigations, changes, improvement projects, technical training, operational excellence, and documentation. You'll serve as a vital link between shift operations teams and day-based cross-functional support, providing timely front-line technical support during all phases of facility and product start-up and ongoing commercial supply. Your expertise will drive technical ownership of upstream and downstream unit operations, offering real-time leadership on process or equipment issues aligned with business strategies and objectives. Additionally, you'll lead projects and improvements at the Dublin facility, encompassing process innovation, automation, product transfers, and continuous improvement.

Accountabilities:

• Manufacturing Technologists are responsible for providing support to the BDS operations at College Park, Dublin.  They help to build and sustain employee engagement by creating a culture of open, efficient execution and an environment in which individuals and teams can excel and continuously improve.

• Leader and provider of expert technical and documentation support to investigations, CAPA’s, change controls, training and improvement projects ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.

• During routine new product introductions, the Manufacturing Technologist team provide end user operations requirements input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams. 

• The Manufacturing Technologist team takes a lead role developing Operations procedures, batch records (electronic or paper as required), other documentation and provide technical training to the Operations teams.

• Manufacturing Technologists 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.

• Manufacturing Technologists successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.

• The Manufacturing Technologist team Develop and maintain strong and effective relationships with partners at College Park 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.

Essential Skills/Experience:

• Experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry (working in an GMP environment).

• Extensive knowledge of a biological manufacturing processes

• Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise.

• Strong problem solving and troubleshooting capability

• Good Presenting and Training Skills

• Good Technical writing skills

• Excellent communications and decision-making skills

• Green Belt in Lean six sigma an advantage

• Proven ability to work well as part of a team & on own with minimum supervision

• Proven leadership skills.

Desirable Skills/Experience:

• Experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations.

• Experience of formulation, aseptic and sterile manufacturing, including, autoclaves, sterile filtration, Vial and Syringe packaging would be an added advantage.

• 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.

• Green Belt in Lean six sigma an advantage.

At AstraZeneca, we are driven by a passion for innovation and a commitment to making a meaningful impact. Our unique blend of entrepreneurial spirit and global resources allows us to redefine careers while protecting our patients, people, and planet. Here, you'll find an environment that encourages autonomy and growth, where you can explore new ideas and develop new skills. We believe in empowering our employees to take ownership of their careers and make a difference in the lives of patients worldwide.

Ready to embark on this exciting journey? Apply now to join our team!

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.