Plant Technologist Regenerative MedicinesApply Now Job ID R0004198 Date posted 09/03/2018 Location:Dublin, Ireland
Reporting directly to the Team Lead Regenerative Medicines, the main purpose for this role is to perform GMP manufacturing operations for a strategic cell therapy product in Takeda’s new regenerative medicines facility in Grange Castle, Ireland (TILGC).
- Scope includes aseptic regenerative medicine manufacturing in a clean room environment including cell therapy products.
- Execute production activities: cell culture, cleaning, environmental monitoring, preparation of media and reagents according to cGMP for aseptic production and biological products.
- Complete daily manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs, and records of equipment and batches as required.
- Ensure timely completion of all SOP, reading, training and assessment.
- Ensure all processing equipment and materials necessary are available, maintained and qualified as required for the different manufacturing activities.
- Ensure the integrity and quality of the products produced in compliance with operating procedures to meet all cGMP, regulatory, and safety requirements.
- Support material management activities (purchase, reception, storage, etc).
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
- Support investigations in manufacturing and technical deviations.
- Ensure the strongest environmental performance possible by proactively and constantly improving control strategies and engagement in own area of responsibility.
- Support achievement of overall operational readiness schedule adherence for the new regenerative medicines facility
- Other duties as required and directed by the Team Lead Regenerative Medicines, TILGC.
General Role Responsibilities:
- Support a culture of open communication, fairness and transparency.
- Participate in required training and qualification activities.
- Support continuous improvement mindset at TILGC.
- Support effective performance management and participate in multi-discipline shift huddle and shift handovers.
- Perform all operations in accordance with Takeda quality standards, GWPs, cGMPs and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
- Foster a safe work environment, ensuring all colleagues maintain safety as a priority.
- Adopt the corporate values of Vision 2025 and Takeda-ism within the workplace.
- Required: laboratory / pharmaceutical manufacturing technologist
- Science, Engineering or BioChemistry degree or other relevant field of expertise an advantage
- At least 3 years’ experience in pharmaceutical manufacturing in the field of aseptic manufacturing operations.
- Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
- Desirable: strong background in cell / tissue culture, preferably with mammalian cell lines (human or animal) and primary cell culture
- Detailed knowledge of aseptic manufacturing operations, as well as Quality and HSE. Familiar with EU GMP regulations specific to aseptic manufacturing.
- Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage
- Basic knowledge of MS Office applications
- Flexible, eye for detail, tidy, neat and organised
- Working hours from Monday to Sunday, including bank holidays
- Strong Quality orientation and safety focus.