With direct supervision, the individual will:
- Perform routine manufacturing operations.
- Operate production equipment according to Standard Operating Procedures (SOPs), Process Control System (PCS), Electronic Batch Records (EBM), Master Formulation Record (MFR) and Checklists/Forms for the production of commercial and/or clinical products.
- Provide buffer preparation support for manufacturing processes in according to EHS guidelines and in a cGMP compliant manner.
- Perform routine and non-routine production operations as per MFR/EBM (if required).
- Perform well-defined SOPs.
- Execute instructions and record data in the EBM system.
- Perform Clean In Place (CIP) /Steam In Place (SIP) activities as per MFR/SOP.
- Perform filter integrity testing (FIT).
- Perform filtration and filter management as per SOP.
- Attain operating knowledge on the Process Control System (PCS).
- Attain operating knowledge on the Manufacturing Execution System (MES).
- Perform equipment cleaning as per SOP.
- Perform equipment monitoring.
- Perform scheduled cleaning of equipment.
- Perform laboratory tasks including but not limited to sampling, pH, conductivity and refractometer measurements (if required).
- Pursue on-the-job training through Competency Assessments to increase knowledge and understanding.
- Record data into logbooks, log-sheets and forms (if applicable).
- Support Alarm/Alert monitoring and report atypical event (if required).
- Perform real time trouble-shooting(if required).
- To participate and resolve process related issues (if required).
- Demonstrate good cleanroom technique in the handling of product and materials.
- Support GMP and Safety audits (if required).
- Perform standardization of equipment (if required).
- Perform 5S housekeeping.
- Support transfer of new processes and commission/validation of new projects (if required).
- Carry out work in a safe manner, notifying management of safety issues and risks.
- Involve in hands-on execution of the plant operations and assist Supervisors in trouble-shooting.
- Actively support continuous improvement initiatives.
- Perform dispensing activities as per Work Order.
- Perform material transportation as per SOP.
- Perform material charging as per MFR/EBM.
- Perform buffer storage activities as per MFR/SOP.
- Support routine safety and GMP walk down and responding to findings (if required).
- Support execution of Corrective/Preventive actions which identified (if required).
- Support change control activities which assigned (if required).
- Meet and maintain training requirements.
- Complete assigned training on time.
- Provide technical training for area personnel.
- Provide input on training material development.
- 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 values and behaviors.
- Any other duties as assigned by supervisor.
Education and Experience Requirements
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.
Up to one year of relevant experience in the biotechnology, pharmaceutical industry.
Nitec in Biotechnology / Chemical Process Technology or related with minimum three years of relevant experience in the biotechnology, pharmaceutical industry.
Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation.
Experience in ERP/MES/control systems applications will be an added advantage.
Able to work on rotating shifts.
Able to support overtime as required.
Able to support production demands with adjusted work schedule.
Able to adhere to EHS/GMP requirement.
Ability to wear appropriate PPE/Cleanroom gowning as per SOP.
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
Ability to lift, pull or push equipment requiring up to 20kg.
Able to work in cold environment (2-8 degrees C).
Able to climb ladders and work on platforms.
Able to perform confine space entrant/attendant (if required).
Key Skills and Competencies
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.