Associate IV Manufacturing -Drug Product
At Alexion Athlone, we manage a brand new aseptic manufacturing facility dedicated to supplying rare and ultra-rare products to our patients. We are expanding our team to foster a culture of excellence in everything we do. Our goal is to deliver on time with the highest quality product for our patients. The Manufacturing Associate IV finishes production tasks on time, applies MCS automation, completes paper batch records, manages SAP materials, performs maintenance, and improves processes.
Accountabilities
Associate IV Manufacturing -Drug Product 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 all ancillary tasks like equipment preparation.
• MA4 will develop and demonstrate individual specialisms as subject matter experts and display technical leadership by acting as ‘Champion’ to drive improvements CI Project and 5S and excellence within specific aspects of the manufacturing operation within their shift team.
• Complete tasks following SOPs and batch records for Alexion products in cGMP setting, focusing on detail and documentation.
• Assist with the investigation of operations deviations through the QMS system, engaging with all relevant personnel and functions as appropriate.
• Assist with the training of colleagues in SOPs, process execution, and equipment operation.
• Provide input into the creation and maintenance of area SOPs and batch records.
• Where necessary, assist in any Facility and Equipment start-up and Validation activities. Provide input on equipment installation, start-up, operation, and troubleshooting to support the introduction of new products into sustaining operations.
• Provide leadership and guidance in the absence of the Manufacturing Supervisor.
• Possess a high level of SME knowledge and experience in at least one area of operations (e.g., Line 1/Line 2).
• Effectively act as an SME within said area.
• Anticipate and troubleshoot operational issues and interface effectively with MCS or equivalent experience.
• Collaborate with Technical Services, QA, Validation and Automation colleagues to address issues.
• Seek the schedule, identify priorities, and organize work teams locally.
• Be a mentor and a trusted source of knowledge, effectively imparting that information and knowledge to others.
• Be a positive example to others in all areas of EHS, GMP, and productivity.
• Act as designee if required to prepare and deliver shift handovers, reporting out to DP LT/TS/Eng.
• Lead and own investigations/Change controls if required.
• Respond to schedule changes to maintain supply.
• Demonstrate a Lean approach and lead by example in this area.
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, parts washers, Autoclaves, 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.
• Lead in investigation / 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.
• More than 3 years’ experience in a cGMP Aseptic Filling manufacturing environment or equivalent experience preferred.
Desirable Skills/Experience
• BA/BS in a scientific field 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 Alexion, AstraZeneca Rare Disease, you will find an environment where work isn’t ordinary. Our closeness to patients brings us closer to our work and each other. With a rapidly expanding portfolio, you will enjoy an entrepreneurial spirit combined with the security of a global pharma. We support your career development through tailored programs designed for skill enhancement and fostering a deep understanding of our patient's journeys. Here, your career is not just a path but a journey to making a difference where it truly counts.
Ready to make an impact? Apply now!
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.