Posted to MedZilla on 10/13/2019

Takeda Pharmaceuticals

Singapore-, Biotechnologist III SR0041305-MZ


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:

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:

Meet and maintain training requirements

Develop and maintain personal development plan

Provide annual performance self-assessment on development plan

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:

Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related

Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology or related and possess more than 2 years of relevant experience in the biotechnology or pharmaceutical industry

Nitec in Biotechnology / Chemical Process Technology or related with more than 5 years of relevant experience in the biotechnology, pharmaceutical industry

May be required to adjust work schedule to meet production demands

May be required to perform as a subject matter expert for equipment and/or system

Ability to following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable

Possess good communication and troubleshooting skills

Full awareness of current Good Manufacturing Practices (cGMP)

Proficient documentation and proficient computer skills

Proficient in aseptic technique where applicable

Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes

Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

Ability to work in and out of 2-8 deg C Cold Rooms with appropriate personal protective equipment if required

Ability to work in confined spaces if required

Ability to work around chemicals (alcohols, acids & bases)

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.

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