Sr Biotechnologist (Pharmaceutical MNC, Office Hours, GMP)

Recruit Express Pte Ltd

Sr Biotechnologist (Pharmaceutical MNC, Office Hours, GMP)

Recruit Express Pte Ltd


Job Nature: Permanent, Contract

Position Level: Experienced, Manager

Job Category: Clinical/Medical, Pharmaceutical, Medical/Life Science, Sciences

Qualification: Diploma, Bachelor's / Honours, Masters / PhD

Salary: Login to view


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
• 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 [Click Here to Email Your Resume]   (Attn: Biotechnologist)

 

Thank You.

 

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

 

Company Overview

 
Singapore’s Largest & Most Preferred Recruitment Company!
As a premier leading recruitment consultancy in Singapore, our success has been a result of our focus in facilitating the success of our Clients in business whilst enhancing the career opportunities for our Candidates.

With our swift expansion across the region, we now have offices in Singapore, Taiwan, Sydney, Kuala Lumpur and Hongkong as well as a partner network in Shanghai and Japan.

We serve with distinction and provide comprehensive staffing needs. As the total recruitment and staffing solutions partner, our goal is to provide our Clients the best staffing solutions through an integrated database network supported by localized content and services.

EA Licence No.: 99C4599
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