Bio-Process Technician (12 months Fixed Term Contract)

Alexion Pharmaceuticals
Employment Type
Not disclosed
Alexion Pharmaceuticals logo

Some opportunities happen only once in a lifetime – like a job where you have the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

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.

You will be responsible for:

  • 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 QTS 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 Zero Defects
  • Where necessary assist in any in 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.

You will need to have:

  • Must be able to work within and adapt to complex electronic systems such 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
  • Level 1 Entry level BSc. or diploma in a relevant vocational, science or engineering subject.
  • Level 2 Core Bioprocess Technician role. 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.

We would prefer for you to have:

  • BA/BS in a scientific discipline or equivalent experience preferred.

Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.