BDS Manufacturing Specialist

AstraZeneca GmbH; Dublin; On-site; EUR 45,000 - 60,000; Full time

Job summary

A global biopharmaceutical company based in Dublin is seeking a Manufacturing Support Specialist. The ideal candidate will possess strong technical writing skills and have a minimum of 2 years’ experience in pharmaceutical manufacturing. You will be responsible for technical documentation, managing change controls, and driving improvement projects. Join a collaborative team committed to operational excellence.

Qualifications

• Minimum of 2 years’ experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company.
• Good knowledge of GMP/HPRA/FDA regulatory requirements.
• Strong technical writing skills.

Responsibilities

• Perform technical writing to edit and create documents to support Manufacturing Operations.
• Assist with management of Change Management and Deviation Management monitoring systems.
• Identify and drive improvement projects for the facility.

Skills

Technical writing

Communication skills

Problem-solving

Presentation skills

Cross-functional collaboration

Education

BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology

Job description

Overview

This is what you will do:

The Manufacturing Support Team provides manufacturing support to complex life changing biological products. Support new product introductions, 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.

Responsibilities

• Perform technical writing to edit and create documents to support Biopharmaceutical Manufacturing Operations. Documents will include Standard Operating Procedures, Work Instructions, Competencies, Master Batch Records, Training Packs, Protocols, Reports, Forms and other written materials.
• Raise, own and participate in change controls while meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
• Assist with management of Change Management and Deviation Management monitoring systems.
• Ownership of Operations related supplier issues (SCAR’s/SICAR’s).
• Identify, own and drive improvement projects for the BDS facility and its supporting processes and functions.
• Participate and/or lead risk assessments for the BDS technical and
• Participate in inspection readiness projects and support internal audits and health authority inspections.
• Collate routine metrics.

Qualifications

• A minimum of 2 years’ experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company, ideally with experience in both upstream and downstream processing.
• Good knowledge of GMP/HPRA/FDA regulatory requirements.
• Strong technical writing skills.
• Self-starter with strong communication, problem-solving and presentation skills.
• Ability to work effectively in the cross-functional environment as well as independently on a consistent basis.
• Work collaboratively in a matrix environment.
• Proven ability to work well as part of a team and on own with minimum supervision.

Preferred

• BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology.

Date Posted

03-Sep-2025

Closing Date

16-Sep-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.