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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.
% of Time
Job Function and Description
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
- 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 possess 0 - 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 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or related with 4 - 6 years of relevant experience in the biotechnology, pharmaceutical industry
- Will work holidays and overtime as required
- May be required to adjust work schedule to meet production demands
Key Skills and Competencies
- May be required to perform as a subject matter expert for equipment and/or systems
- 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 skills
- Possess good 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)