Primary objectives of this job :
With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture and Purification areas. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products.
Primary responsibilities include:
- Execution of routine and critical production operations.
- Learn and perform well-defined SOPs.
- Pursue on-the-job training through Competency Assessments to increase knowledge and understanding.
- Execute instructions and record data in the Electronic Batch Management (EBM) system if applicable.
- Execute instructions and record data in the Master Batch Records (MBRs) and Master Formulation Records (MFRs) if applicable.
- Attain operating knowledge of the Process Control System (PCS).
- Record data into logbooks and log sheets.
- Review logbooks and log sheets data.
- Perform equipment monitoring.
- Perform basic laboratory tasks including but not limited to sampling, pH and conductivity measurements.
- Demonstrate aseptic technique in the handling of product and materials if applicable.
- Troubleshoot and resolve process related issues.
- Initiate and document production events in the Global Event Management System (GEMS) or equivalent system.
- Propose document revisions.
- Complete required training on time.
- Carry out work in a safe manner, notifying management of safety issues and risks.
The individual will manage equipment and support facility related projects by:
- Performing scheduled cleaning of equipment.
- Assisting in the assembly and disassembly of process equipment.
- Performing standardization of equipment.
- Performing basic 5S housekeeping.
- Initiating Corrective Work Orders in the C3ME system or equivalent system.
- Supporting change over activities.
Staff Technical Training and Development:
- Meet and maintain training requirements.
- Develop and maintain personal development plan.
- Provide annual performance self-assessment on development plan.
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct.
- Any other duties as assigned by supervisor.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.