Manufacturing Associate II

Job Title: Manufacturing Associate III

Introduction to role:
Are you ready to be part of a team that delivers life-changing medicines? At Alexion Athlone, we manage a brand new aseptic manufacturing facility dedicated to crafting rare and ultra-rare products for our patients. We're on a mission to build a culture of manufacturing excellence, ensuring timely delivery and the highest quality standards. In this role, you'll complete production schedules, manage batch records, check maintenance, and improve processes.

Accountabilities:
• Independently perform all core production tasks in areas such as Formulation, Compounding, Pooling, Washing, Autoclaving, Sterilisation, Aseptic Filling, Visual Inspection, and equipment preparation.
• Complete tasks based on SOPs and batch records in a cGMP environment, paying close attention to detail and documentation skills while adhering to ALCOA+ principles.
• Assist in investigating operational deviations through the QMS system, collaborating with relevant personnel and functions.
• Train colleagues in SOPs, process execution, and equipment operation.
• Contribute to the creation and maintenance of area SOPs and batch records.
• Support Facility and Equipment start-up and Validation activities, providing input on equipment installation, start-up, operation, and troubleshooting for new product introductions.
• Serve as an effective SME within the designated area.
• Anticipate and troubleshoot operational issues while interfacing effectively with MCS or its equivalent experience.
• Work together with collaborators such as Technical Services, QA, and Automation colleagues to address issues.
• Mentor and share knowledge effectively with others.
• Exemplify positive behavior in EHS, GMP, and productivity.
• Act as designee when required for shift handovers and reporting to DP LT/TS/Eng.
• Lead and own investigations/change controls when necessary.
• Respond to schedule changes to maintain supply.
• Show a Lean approach and lead by example.

Essential Skills/Experience:
• Must have 1-3 years experience in a Manufacturing Associate position
• 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 QMS deviations
• 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
• More than 1 years experience in a cGMP Aseptic Filling manufacturing environment, or equivalent experience preferred

Desirable Skills/Experience:
BA/BSc in a scientific discipline 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's Alexion division, you'll find an environment where innovation thrives. Our patient-driven culture values diversity and inclusion, fostering connections that lead to groundbreaking ideas impacting patients' lives. We celebrate achievements while supporting each other with kindness. Our commitment extends beyond our work; we take pride in giving back to the communities we serve.

Ready to make a difference? Apply now to join our team!

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