Job Description :
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 re[email protected] (Attn: Biotechnologist - Leon)
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
#HDC
If you meet the requirements of this role, please email a detailed resume in Word document to Leon Leong De Cong.
CEI Registration No.: R1551708
Email: [email protected]
.All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified
Singapore

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