Manufacturing Associate II

Job Title: MA 11

Introduction to role:
Are you ready to make a difference in the world of biopharmaceuticals? As a Drug Product Manufacturing Associate at the Alexion Athlone Manufacturing Facility, you'll play a pivotal role in ensuring operational readiness and excellence. You will be proficient in various unit operations in the Fill Finish manufacturing process, driving batch operations with precision and under limited supervision. Dive into a dynamic environment where your skills will contribute to life-changing medicines!

Accountabilities:
- Operate manufacturing equipment and instruments
- Complete assigned tasks in a timely manner
- Conduct daily activities in an organized, efficient manner
- Perform simple, routine, complex, and critical operations
- Troubleshoot equipment issues, when necessary
- Ensure process equipment is appropriately maintained for operation
- Perform and document operations in accordance with cGMP’s
- Execute equipment qualification protocols and validation protocols
- Routinely draft/create and revise standard operating procedures, manufacturing batch records, and other documents as required
- Recognize, initiate process deviations and perform deviation investigations and closure
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
- Embrace Alexion Core Competencies
- Maintain training compliance and train other staff
- Communicate effectively, written and verbal
- Ensure a safe working environment for all staff
- Plan daily activities and schedule operations
- Interact with other departments
- Aseptic Filling with RABS in grade B background
- Compounding/Formulation of products
- Sterile Filling of vials/syringes using Isolator
- Visual Inspection of finished product
- Cleaning and Sanitation of equipment
- Operation of Parts washers and Autoclaves
- CIP/SIP of Vessels
- Support regulatory audits
- Support all new product/process introductions on site
- Perform data collection, compilation, and statistical analysis
- Interact with vendors and outside resources
- Complete assigned projects
- Be the shift lead if required, providing instruction to the team
- Troubleshoot and resolve operational problems during processing
- Represent Manufacturing in cross-functional initiatives and meetings
- Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
- Manage multiple projects independently
- Plan and implement complex changes
- Perform Environmental monitoring as required
- Technical expert for entire area(s)
- Interact independently with regulatory agencies
- Develop and provide training on complex manufacturing processes
- Perform Manufacturing review and approval of critical documents
- Develop process validation protocols
- Maintain good housekeeping and clean and sanitize classified areas as required
- Analyze complex problems and determine and implement solutions

Essential Skills/Experience:
- Able to work within and adapt to complex electronic systems such as SAP and EQV
- Able to read, write, and converse in English
- Have good working knowledge of MS Excel and Word
- Ability to work in an intense, fast-paced work environment
- Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
- Ability to work independently and as part of a team
- 2 years + experience in a cGMP biopharmaceutical manufacturing environment

Desirable Skills/Experience:
BA/BSc in a scientific field or equivalent experience.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find yourself immersed in a culture that thrives on innovation and collaboration. Our commitment to patients drives everything we do, fostering an environment where your ideas can flourish. With a rapidly expanding portfolio, you'll have the chance to grow alongside exceptional leaders who are dedicated to making a difference. Here, your career is more than just a path; it's a journey towards impactful change.

Ready to take the next step? Apply now to join our team!

Date Posted

17-Sep-2025

Closing Date

17-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.