Primary Objectives of this Job
With limited 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. Will support engineering and validation activities.
Primary responsibilities include (70%):
- 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
- Review manufacturing documentation and EBM or PCS alerts real-time to ensure compliance 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 and coordinate 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
- Informing management of events impacting production schedule
- Propose and review 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 (15%):
- Act as a Subject Matter Expert SME for improvement projects
- Perform scheduled cleaning of equipment
- Assist in the assembly and disassembly of process equipment
- Perform standardization of equipment
- Perform basic 5S housekeeping
- Initiate Corrective Work Orders in the C3ME system or equivalent system.
- Support change over activities
Staff Technical Training and Development (15%):
- Meet and maintain training requirements
- Provide technical training for area personnel
- Provide input on training material development
- 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.
Education and Experience Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses up to 2 years of relevant experience in the biotechnology or pharmaceutical industry
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess more than 5 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or related with up to 7 years of relevant experience in the biotechnology, pharmaceutical industry
- Excellent self-motivated team player with hands-on attitude and good communication skills
- Able to work on rotating shift
- Will work holidays and overtime as required
- May be required to adjust work schedule to meet production demands
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.