Manufacturing Technologist

Alexion Pharmaceuticals

Dublin
Permanent
Full-time

30 days ago

The Manufacturing Technologist Team provides manufacturing support to complex life changing biological products. Support new product introductions, process monitoring, investigations, changes, improvement projects, technical training, operational excellence and documentation. The team provide a key interface between the shift operations teams and day-based cross functional support. Manufacturing Technologists provide key timely front line Operations technical support to the BDS processes during all phases of facility and product start up and into ongoing commercial supply.The Manufacturing technologists 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 Technologists are also responsible for the successful execution of projects and improvements identified as part of the Dublin 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 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.

You will need to have:

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.
Other duties as required

We would prefer for you to have:

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.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.

Alexion Pharmaceuticals

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