Sr Biotechnologist (Pharmaceutical, Upstream, Mfg/ Equipment Support) - Jobs in Singapore 1512691

Recruit Express Pte Ltd
Job Summary
  • Experience 3-7 Years
  • Job Type
    Permanent
  • Telecommuting
    N/A



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    (Attn: Biotechnologist - Leon)


 


Thank You.




Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599


 


Profile Summary

Type : Company job

Role : N/A

Industry : Medical/Life Science

Salary : N/A

Deadline: 2020-08-11

Company Profile

N/A
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