Job Information
Takeda Pharmaceuticals Biotech III (MFG Support) - 12 Months Contract in Singapore, Singapore
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Job Description
Job Title: Biotech III (MFG Support) - 12 Months Contract
Location: Singapore
About the role:
With general supervision the individual will perform routine manufacturing operations. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products. Provide equipment preparation support for manufacturing processes in according to EHS guidelines and in a cGMP compliant manner.
How you will contribute:
(80%)The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Electronic Batch Records (EBM), Batch Records and Forms. Primary responsibilities include:
Perform routine and non-routine production operations as per SOPs
Execute instructions and record data in the Electronic Batch Management (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 good operating knowledge of the Process Control System (PCS)
Attain good operating knowledge on the Manufacturing Execution System (MES)
Perform equipment cleaning as per SOP
Perform equipment monitoring
Perform scheduled cleaning of equipment
Acquire good knowledge in handling of consumables (e.g. Bottles, filters, autoclave assemblies, etc.)
Perform laboratory tasks including but not limited to sampling, pH and conductivity measurements (If required), identify and report if there’s any atypical events
Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
Record data into logbooks, log-sheets and forms (If applicable)
Responsible for Alarm/Alert review and real time troubleshooting
Responsible for logbooks and log-sheets review and follow up
Perform troubleshooting and resolve process related issues
To participate and resolve process related issues (If required)
Support transfer of new processes, commission or validation of new project
Collaborate with other departments to resolve issues related to daily operations
Training of new team members.
Demonstrate good cleanroom technique in the handling of product and materials
Coordinate in-process sampling and submission
Mentor and perform On-Job-Training to team members
Support GMP and Safety audits (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 troubleshooting
Actively participate in continuous improvement initiatives
Perform components staging for autoclaving and parts washer
Perform assembly and disassembly of process equipment
Perform parts washer operation as per SOPs
Perform loading and Operating of Autoclave
Responsible for MFR (Manufacturing Formulation Record)/SOP creation and revision
Perform monitoring for process and equipment performance during operation as per SOP/MFR, identify and report if there’s any atypical events
Support investigation to event and deviation
Interface with other departments to resolve issues related to daily operations
Actively support transfer of new processes and commission/validation of new projects
Actively support Change Control management
(10%)The individual will manage equipment and support facility related projects by
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)
Act as a SME for investigation and solution
Liaise with other department for Corrective/Preventive actions which identified
Support shift change/handover activities
(10%) Staff Technical Training and Development
Meet and maintain training requirements
Complete assigned training on time
Provide technical training for area personnel
Provide input on training material development
Deputize for shift supervisor’s activities
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.
What you bring to Takeda:
Education and Experience Requirements
Degree in Biomedical Sciences / Chemical Engineering or related with 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 with 2 - 4 years years of relevant experience in the biotechnology, pharmaceutical industry
Nitec in Biotechnology / Chemical Process Technology or related with minimum five years of relevant experience in the biotechnology, pharmaceutical industry
Knowledge of plant and unit operations (autoclave, parts washers, COP and SIP systems)
Demonstrate commitment to cGMP, EHS compliance aspects of clean-room and plant operation
Experience in ERP/MES/control systems applications will be an added advantage
Able to take initiative with good problem-solving skills
Excellent team player with hands-on attitude
Able to work on rotating shifts
Able to support overtime as required
Able to support production demands with adjusted work schedule
Adhere to all 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 climb ladders and work on platforms
Able to perform confine space entrant/attendant/Supervisor/Assessor (If required)
Key Skills and Competencies
The individual should have moderate understanding of general job aspects and moderate understanding of the detailed aspects of the job.
Possess good communication skills
Possess adequate documentation and computer skills
Possess adequate troubleshooting skills • Familiar with current Good Manufacturing Practices (cGMP)
Ability to read/understand Safety Data Sheet (SDS) and handle chemicals as per SOP
Able to monitor and analyze processing parameters to identify atypical trends
Able to support Continuous Improvement Projects
Able to perform as a subject matter expert for equipment and/or systems
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
SGP - Singapore - Woodlands
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time
Takeda Pharmaceuticals
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