Biotech III

About the Role:

We are seeking a highly skilled Biotech III to join our team at Takeda. As a Biotech III, you will play a critical role in ensuring the smooth operation of our manufacturing processes.

Key Responsibilities:

• Perform routine and non-routine production operations in accordance with Standard Operating Procedures (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

Additional Responsibilities:

• 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

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.