Expanding BioPharma Client in North-West Dublin requires experienced BioProcess Technicians (Level 3) on an initial 12-month contract, for their new BioPharma Start-up facility to perform all core production tasks in the areas of cell culture, media prep, purification, buffer preparation and all ancillary tasks such as equipment preparation.
- 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. Role requires people leadership skills.
- 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 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.
- BA/BSc in a scientific discipline
- 4+ years' experience in a similar role within a GMP biotech manufacturing environment
- 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 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
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