Bio-Process Technician

Reports to:        Manufacturing Shift Lead

Location:           Monksland, Athlone,

Position Summary

At the Alexion Bulk Drug Substance facility in Athlone, we are a state-of-the-art bio-manufacturing facility.

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 paper batch records, SAP materials consumption, routine maintenance checks and continuous improvement of the work processes and environment.

Principal Responsibilities

• 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
• 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, 6S) to optimize efficiency and drive the culture of Continuous Improvement and Zero Defects

• 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.

Qualifications

• Must be able to work within and adapt to complex electronic systems such as process automation, SAP and EQV 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, 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.

Education

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