The Bio-Process Technician is a vital member of a high-performing, empowered 24/7 shift team. You will be responsible for executing production according to schedule using MCS automation, completing paper batch records, SAP materials consumption, routine maintenance checks, and continuously improving work processes and the environment. Are you ready to take on this exciting challenge?
Accountabilities:
* 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.
* Develop and demonstrate individual specialisms as subject matter experts and display technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team.
* Follow SOPs and batch records for Alexion product prep and production in a cGMP setting, emphasizing attention to detail and superb documentation.
* 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.
* Assist in any Facility and Equipment start-up and Validation activities. Provide input on equipment installation, start-up, operation, and troubleshooting to support the introduction of new products into sustaining operations.
* Act as an effective process leader within said area.
* Anticipate and troubleshoot operational issues and interface effectively with MCS.
* Engage with stakeholders including Technical Services, QA, and Automation colleagues to resolve issues.
* Seek the schedule, identify priorities, and organize work teams locally.
* Be a mentor and a trusted source of knowledge, effectively imparting that information and knowledge to others.
* Be a positive example to others in all areas of EHS, GMP, and productivity.
* Act as designee if required to prepare and deliver shift handovers, reporting out to Biologics LT/TS/Eng.
* Lead and own investigations/Change controls if required.
* Demonstrate a Lean mindset and lead by example in this area.
* 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.
Essential Skills/Experience:
* Must be able to work within and adapt to complex electronic systems such as 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, 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.
* Be competent in most areas of Upstream and Downstream.
* Perform MBR Reviews.
* Perform TrackWise deviations.
* Be an area lead and motivate others to keep schedules maintained.
* Highlight any issues that arise in production and contact the relevant departments for support as required.
Desirable Skills/Experience:
* BA/BS in a scientific discipline or equivalent experience.
Ready to make a difference? Apply now!
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