West Dublin, Dublin West
Principal Responsibilities All 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. 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 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. Skills Qualifications: 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. Requires 8+ years’ experience in a cGMP biotech manufacturing environment. Competencies: 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. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
79 days ago