The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Electronic Batch Records (EBM), Batch Records and Forms.
Primary responsibilities include:
80%
• 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 trouble-shooting
• 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 trouble-shooting
• 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 Code of Conduct.
Education and Experience Requirements
• Min Degree in Biomedical Sciences / Chemical Engineering or related with up to three years of relevant experience in the biotechnology, pharmaceutical industry
• Min 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 minimum two years of relevant experience in the biotechnology, pharmaceutical industry
• Min 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)
• 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
If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: Biotechnologist)
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
