Biotechnologist (Pharmaceutical, Healthcare, Medical, MNC)

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%

1. Perform routine and non-routine production operations as per SOPs
2. Execute instructions and record data in the Electronic Batch Management (EBM) system
3. Perform Clean-In-Place (CIP) /Steam-In-Place (SIP) activities as per MFR/SOP
4. Perform filter integrity testing
5. Perform filtration and filter management as per SOP
6. Attain good operating knowledge of the Process Control System (PCS)
7. Attain good operating knowledge on the Manufacturing Execution System (MES)
8. Perform equipment cleaning as per SOP
9. Perform equipment monitoring
10. Perform scheduled cleaning of equipment
11. Acquire good knowledge in handling of consumables (e.g. Bottles, filters, autoclave assemblies, etc.)
12. Perform laboratory tasks including but not limited to sampling, pH and conductivity measurements (If required), identify and report if there’s any atypical events
13. Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
14. Record data into logbooks, log-sheets, and forms (If applicable)
15. Responsible for Alarm/Alert review and real-time troubleshooting
16. Responsible for logbooks and log-sheets review and follow up
17. Perform troubleshooting and resolve process-related issues
18. To participate and resolve process-related issues (If required)
19. Support transfer of new processes, commission or validation of new project
20. Collaborate with other departments to resolve issues related to daily operations
21. Training of new team members
22. Demonstrate good cleanroom technique in the handling of product and materials
23. Coordinate in-process sampling and submission
24. Mentor and perform On-Job-Training to team members
25. Support GMP and Safety audits (If required)
26. Perform 5S housekeeping
27. Support transfer of new processes and commission/validation of new projects (If required)
28. Carry out work in a safe manner, notifying management of safety issues and risks
29. Involve in hands-on execution of the plant operations and assist Supervisors in troubleshooting
30. Actively participate in continuous improvement initiatives
31. Perform components staging for autoclaving and parts washer
32. Perform assembly and disassembly of process equipment
33. Perform parts washer operation as per SOPs
34. Perform loading and Operating of Autoclave
35. Responsible for MFR (Manufacturing Formulation Record)/SOP creation and revision
36. Perform monitoring for process and equipment performance during operation as per SOP/MFR, identify and report if there’s any atypical events
37. Support investigation to event and deviation
38. Interface with other departments to resolve issues related to daily operations
39. Actively support transfer of new processes and commission/validation of new projects
40. Actively support Change Control management

10%

The individual will manage equipment and support facility related projects by:

1. Support routine safety and GMP walk down and responding to findings (If required)
2. Support execution of Corrective/Preventive actions which identified (If required)
3. Support change control activities which assigned (If required)
4. Act as a SME for investigation and solution
5. Liaise with other department for Corrective/Preventive actions which identified
6. Support shift change/handover activities

10%

Staff Technical Training and Development:

1. Meet and maintain training requirements
2. Complete assigned training on time
3. Provide technical training for area personnel
4. Provide input on training material development
5. Deputize for shift supervisor’s activities
6. 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

1. Min Degree in Biomedical Sciences / Chemical Engineering or related with up to three years of relevant experience in the biotechnology, pharmaceutical industry
2. 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
3. Min Nitec in Biotechnology / Chemical Process Technology or related with minimum five years of relevant experience in the biotechnology, pharmaceutical industry
4. Knowledge of plant and unit operations (autoclave, parts washers, COP and SIP systems)
5. Demonstrate commitment to cGMP, EHS compliance aspects of clean-room and plant operation
6. Experience in ERP/MES/control systems applications will be an added advantage
7. Able to take initiative with good problem-solving skills
8. Excellent team player with hands-on attitude
9. Able to work on rotating shifts
10. Able to support overtime as required
11. Able to support production demands with adjusted work schedule
12. Adhere to all EHS/GMP requirement
13. Ability to wear appropriate PPE/Cleanroom gowning as per SOP
14. Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
15. Ability to lift, pull or push equipment requiring up to 20kg
16. Able to climb ladders and work on platforms
17. Able to perform confined 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 leonleong@recruitexpress.com.sg (Attn: Biotechnologist)

Thank You.

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