Alexion Pharmaceuticals Process Technician in Ireland
At the new Alexion Bulk Drug Substance facility in College Park, Dublin we are constructing a new state of the art bio-manufacturing facility. We are also 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 Bio-Process Technician is a member of a high performing, empowered shift team, responsible for executing 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.
Bioprocess technicians will be trained and competent 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.
Bioprocess technicians will also develop and demonstrate individual specialisms as subject matter experts and are required to display technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team.
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 Trackwise system, engaging with all relevant personnel and functions as appropriate.
Assist where necessary 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 Right First Time execution.
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 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.
Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
Must possess strong verbal and written communication skills
Must be able to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system.
In-depth knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs would be considered an advantage.
Familiarity with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems considered an advantage
Level 1 Entry level BSc. or diploma in a relevant vocational, science or engineering subject.
Level 2 Requires 3+ years’ external experience in a cGMP biotech or closely allied pharmaceutical manufacturing environment, or 1.5 - 2 years at Level 1 and demonstration of appropriate competencies.
BA/BSc in a scientific discipline or equivalent experience preferred.
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: Fosters open dialog 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.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.