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alexion

Manufacturing Specialist, Packaging Operations

Location: Dublin, Ireland Job reference: R-188788 Date posted: 01/09/2024

This is what you will do:

At the Alexion Astra Zeneca Rare Disease Unit at College Park we run a fast paced and diversified Packaging Operations facility.  We have also established a high performing team committed to creating a manufacturing culture of excellence in everything we do. We are committed to on time delivery of the highest quality product to our patients.

The Manufacturing Support Specialist 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 specialist provides a key interface between the shift operations teams and day-based cross functional support. Manufacturing Specialists provide key timely front-line Operations technical support to the packaging processes during all phases of clinical and commercial supply.

The Manufacturing Specialist responsibilities include the ownership of packaging technical investigations and CAPA’s on any process, equipment or materials issues, and technical equipment assessments and documentation writing, in line with business strategies and objectives.

The Manufacturing Specialists are key for the supporting of successful execution of projects and improvements identified as part of the Dublin facility priority list. These projects 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:

  • Take an active role in setting up and improving work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
  • To actively monitor and trend investigation and error topics to ensure appropriate and proactive improvements are implemented and ensure that all associated KPI targets are achieved.
  • Perform technical writing and related editing functions to prepare documents to support Packaging Manufacturing Operations and related Regulatory Submissions.
    Documents will include Standard Operating Procedures, Work Instructions, Packaging Instructions, Competencies, Master Batch Records, Training Packs, Protocols, Reports, Forms and other written materials.
  • Helps define documentation standards and trains and supports others in documentation best practices.
  • Create, review & approve manufacturing technical and procedural documentation as needed
  • Provides training to others, where applicable, on documents generated.
  • Works independently and/or within a team to accomplish job objectives.
  • Establishes and follows priorities in assigned workload to meet department and Company objectives.
  • Lead, author and co-ordinate Good Manufacturing Practice deviations through the CAPA management system (Trackwise). This will involve structured problem solving of problems encountered and the implementation of robust CAPA, where required.
  • Raise, own and participate in change controls, training and improvement projects while meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
  • Establishes and maintains effective working 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
  • Assist with setup and management of Change Management and Deviation Management monitoring systems.
  • Collate and help drive routine metrics.
  • Generate, track and catalogue Manufacturing Records, Batch related documents and forms
  • Attend and or chair daily operations meetings as required.
  • Participate in Audit Preparation.
  • Supports Regulatory audits and inspections in a direct or indirect capacity.
  • Supports wider business objectives in relation to Corporate and Social Responsibilities.

You will need to have:

  • 3-5 years experience in a fast paced and technical packaging manufacturing facility
  • History of complete ownership of tasks, including improvement projects and technical system/process/product introductions
  • Must be able to work on own initiative as well as bring others along.
  • Must have proven problem solving skills and ability to think logically.
  • Must be technically astute.

We would prefer for you to have:

  • Bachelors Degree in Science or enigineering based program or equivalent
  • Proven track record of creating and maintaining techincal and operational spcifications/documentation.

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.

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