Bio-Process Technician III

Introduction to role:

At the new Alexion Bulk Drug Substance facility in College Park, Dublin, we are constructing a state-of-the-art bio-manufacturing facility. We are building our team to create a manufacturing culture of excellence in everything we do. We will deliver on time for our patients with the highest quality product. The Level 3 Bio-Process Technician is a senior-level subject matter expert and a hands-on member of a high-performing, empowered shift team, responsible for completing production according to schedule using MCS automation, completing electronic batch records, SAP materials consumption, routine maintenance checks, and continuous improvement of the work processes and environment. This senior-level role requires additional skills, responsibility, and leadership ability and is not an automatic progression from Level 2.

Accountabilities:

• All bioprocess technicians will be trained and proficient to independently perform all core production tasks in the areas of cell culture, media preparation, purification, buffer preparation, and all ancillary tasks such as equipment preparation.
• Role requires people leadership skills and the ability to frequently act as designee for the shift lead (manager level) and to act as decision maker across multiple interdependent functions including operations and maintenance.
• The level 3 bioprocess technician will also develop and demonstrate individual specialisms as subject matter expert across multiple process technologies.
• Adept at gathering and analysing process and operational performance data and leading operational process improvements.
• Display technical leadership and specialisation by acting as ‘Champion’ and leading improvement initiatives across shifts and functions.
• Responsible for execution of all tasks associated with the preparation for and production of Alexion products in cGMP environment ensuring full attention to detail and excellent documentation skills.
• Assist in maintaining a safe, cGMP compliant work environment at all times.
• Responsible for completion of tasks according to SOPs and batch records (paper and electronic).
• Perform initial troubleshooting of issues identified during routine operations.
• Assist with the investigation of and operations deviations through the QTS system, engaging with all relevant personnel and functions as appropriate.
• Assist where vital 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.
• Seek and implement opportunities for Continuous Improvement.
• Use Lean Tools as part of daily operations (Standard Work, 5S, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement and Zero Defects.
• Where vital 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.
• Shift working is required. The shift pattern may be varied according to business requirements and will typically require weekend working and periodic rotation between day and night shifts.

Essential Skills/Experience:

• Proven technical leadership and complex decision-making abilities in a biotech operating environment.
• Must be able to work within and adapt to complex electronic systems such as process automation, SAP, and Trackwise investigation system.
• Must have in-depth knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs.
• Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves/glass washers, media/buffer systems, and purification systems.
• Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
• Must possess strong verbal and written communication skills.
• Requires 8+ years’ experience in a cGMP biotech manufacturing environment.
• BA/BS in a scientific field or equivalent experience preferred.

Desirable Skills/Experience:

• Accountability: Holds self and others accountable for delivering results and puts patients first.
• Decision Quality: Considers all relevant factors and uses appropriate decision-making criteria and communicates these appropriately.
• Collaboration: Champions open dialogue and communication.
• Cultivates Innovation: Can take a creative idea and put it into practice.
• Perspective: Looks toward the broadest possible view of an issue/challenge.
• Planning: Accurately scopes out length and difficulty of tasks and projects.
• Problem-solving: Uses rigorous logic and methods to solve difficult problems with effective solutions.
• Drive for results: Can be counted on to exceed goals successfully.
• Time Management: Can attend to a broad range of activities.
• Perseverance: Pursues everything with energy, drive, and a need to finish.

At Alexion, AstraZeneca Rare Disease, we push the boundaries of science to transform lives. Our dedication to transparency, objectivity, and ethics drives us to develop transformative medicines for rare diseases. With our global reach and resources, we are uniquely positioned to address unmet medical needs. Our culture fosters innovation, collaboration, and personal growth. Join us in making a meaningful impact on patients' lives.

If you are ready to make a difference where it truly counts, 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.