Manufacturing Associate IV

Job Title: Manufacturing Associate IV

Introduction to role:
At Alexion Athlone, we pride ourselves on our state-of-the-art aseptic manufacturing facility, dedicated to delivering rare and ultra-rare products to our patients. We are committed to fostering a culture of excellence in manufacturing, ensuring timely delivery of the highest quality products. As a Manufacturing Associate IV, you will be an integral part of a high-performing team responsible for executing production schedules using MCS automation, completing paper batch records, SAP materials consumption, routine maintenance checks, and driving continuous improvement in our work processes and environment.

Accountabilities:
The Manufacturing Associate IV will be trained and competent to independently perform all core production tasks in areas such as Formulation, Compounding, Pooling, Washing, Autoclaving, Sterilization, Aseptic Filling, Visual Inspection, and equipment preparation. You will develop individual specialisms as subject matter experts and display technical leadership by acting as a 'Champion' to drive improvements within specific aspects of the manufacturing operation. Responsibilities include executing tasks according to SOPs and batch records in a cGMP environment, assisting with operations deviations investigations, training colleagues, providing input into SOPs and batch records creation, supporting equipment start-up and validation activities, and providing leadership in the absence of the Manufacturing Supervisor.

Essential Skills/Experience:
- Must be able to work within and adapt to complex electronic systems such as process automation, SAP, and Trackwise QMS investigation system.
- Must have in-depth knowledge of Vial/Syringe Filling manufacturing processes and their translation into documentation such as batch records and SOPs.
- Must be familiar with Aseptic equipment and systems such as RABS, Isolators, glass washers, GIT’s, FIT’s, Capping, CIP&SIP of Vessels, VI machines, and WFI systems.
- Working knowledge of the requirements of Grade A, B & C Manufacturing Environments.
- Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
- Must possess strong verbal and written communication skills.
- Perform MBR Reviews.
- Perform TrackWise deviations.
- Be an area lead and motivate others to keep schedules maintained.
- Highlight any issues that arise in production and contact the relevant departments for support as required.
- Ability to work independently and as part of a team.
- Availability to work Shift.
- More than 3 years experience in a cGMP Aseptic Filling manufacturing environment or equivalent experience preferred.

Desirable Skills/Experience:
BA/BS in a scientific discipline or equivalent experience preferred.

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's Alexion division, you'll find an environment where work is more than just a job—it's a mission. Our closeness to patients drives our commitment to innovation and collaboration. With a rapidly expanding portfolio and an entrepreneurial spirit, we offer a unique blend of biotech agility with global biopharma resources. You'll be part of a culture that values diversity, fosters connections, and empowers you with tailored development programs. Here, your career is not just a path but a journey to make a meaningful impact on patients' lives.

Ready to make a difference? Apply now and join us on this exciting journey!

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