ATTACH AND TRAIN PROGRAMME FOR BIOLOGICS MANUFACTURING (AnT Biologics)

Objective & Scope of Programme

The ATTACH AND TRAIN PROGRAMME FOR BIOLOGICS MANUFACTURING (AnT Biologics) (Replace LOCAL Biologics Skills Training Programme or Local Boost) is a manpower talent development programme aims at building up a pipeline of skilled manpower for Singapore's biologics manufacturing industry. This programme is jointly supported by the Workforce Singapore (WSG) and Singapore Polytechnic (SP). Trainees undergo 262 hours of WSQ trainings leading to WSQ Higher Certificate in Process Technology (Biologics Manufacturing) and 18-21 months of structured on-the-job training (OJT) with leading biologics companies to deepen their technical competencies and work skills. Trainees who successfully complete the programme are highly sought after as the biopharmaceutical industry in Singapore is rapidly growing and expanding.

 

Programme Details

Programme Duration: 262 hours (estimated 2-3 months of full time training at SP)

Programme Commencement Period: (MAY 2019)

Date for application: 29 JAN 2019 - 22 MAR 2019

Participating company for MAY 2019:

• Roche Singapore Technical Operations Pte Ltd
• Lonza Biologics Tuas Pte Ltd

Throughout the entire OJT period, trainees are attached to one of the participating companies & trained in one or more areas outlined below:

(1) Manufacturing

• Responsible for completing assigned tasks which may include preparing equipment, cleaning and sterilizing vessels, preparing solutions, monitoring and operation bioprocessing equipment, raw materials sampling and dispensing, environmental monitoring sampling and housekeeping of the areas while adhering to Safety, cGMP and Biopharmaceutical Manufacturing guidelines.

(2) Quality

(A) Compliance

• Support and participation of inspection related activities, which includes Health Authorities inspections, self-inspection and inspection readiness activities.
• Support Supplier and Service provider program, Quality Compliance program and creation and oversight of Quality Compliance performance metric

(B) Manufacturing Quality Assurance (MQA)

• Provide QA oversight on manufacturing floor and ensure that Investigational Medicinal Products (IMPs) and commercial medicinal products are manufactured in accordance with current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP) guidelines.
• Provide QA oversight for discrepancies to ensure quality and compliance of these activities to company guidelines and Health Authority (HA) requirements.

(C) Quality Control (QC)

• Performance of testing (e.g. water sampling, raw material, in process control, release and stability) in accordance with cGMP regulations and standards. Other activities include housekeeping, reagent preparation, inventory and lab supplies and calibration and maintenance of QC equipment.
• Support investigation and studies for lab related discrepancies and improvement projects (e.g. testing method validation).

(3) Manufacturing, Science and Technology (MSAT)

(A) Process Automation

• Responsible for validation of Automation Systems, batch operations and configuration of phases & recipes, process system maintenance, configuration of control/equipment modules, fieldbus/device net, Profi-Bus and alarm management.
• Troubleshooting of Process Automation Systems, audit/inspection support and operational excellence.

(B) Process / Validation Engineering

• Optimizing and improving manufacturing processes and equipment performance on mammalian cell culture and bacterial cell culture platforms using validation principles/approaches, process monitoring, process validation, equipment/facilities/utilities validation, cleaning validation and techniques.
• Process troubleshooting and Root Cause Analysis (RCA), process development lab operation, audit/inspection support and operational excellence.
• Education requirement: Degree in Engineering or Science discipline

(4) Facilities & Engineering (F&E)

(A) Maintenance

• Maintain Plant process through development & implementation of maintenance procedures & instructions, management of spares part inventory, and analysis of maintenance data to drive continuous improvement in equipment reliability & uptime.
• Facilitate, participate and review discrepancy root cause analyses, timely close out investigation report and follow up on all corrective actions & preventive actions.
• Manage and supervise a team of maintenance shift crew responsible for maintenance, calibration and repair of equipment during routine & shutdown maintenance work.

(B) Utilities

• Maintain Plant process, routine operations and maintenance work in Utilities.
• Implement changes through change control process.
• Drive continuous improvement and waste reduction, through implementation of cross functional projects.

(C) Facilities Management

• Collaborate with internal stakeholders to carry out technical reviews for indirect contract renewals and providing procurement services within the department.
• Identify areas of Continuous Improvements to bring about value enhancements to Facilities Management Operations through Kaizen implementation.
• Support company’s sustainability effort and local authority data collection/analysis for reporting.

(D) Reliability

• Data analysis to support site improvement
• Support/ Lead continuous projects such as Kaizens or for Lean Production System
• Support Reliability projects and programs such as ACE, FMEA, ARA and ELEE
• Facilitate cross-functional discussions such as Root-Cause-Analysis
• Education requirements - Diploma in Electrical, Instrumentation, Chemical Process, Mechanical Engineering




Suitable for

a. Singapore citizens or Singapore permanent residents;
b. Candidates with at least a NITEC/Higher NITEC/Diploma/Degree from any disciplines;
c. Candidates without prior working experience in the biopharmaceutical manufacturing industry*;
d. Fresh graduates who are keen to join the industry, junior hires or mid-career professionals who are switching out of other industry.

*Individuals who are current or were ex-student interns from a biopharmaceutical company are eligible to apply.

Application Process & Selection Criteria

You are to refer to the Application Procedure for AnT-Biologics Mfg. It requires you to download an application form in this Website, complete and submit it together with educational certificates and transcripts. It is important that you indicate the trainee position(s) that you are interested to apply in the application form. You can indicate one or more trainee positions. For further details on the submission of application, please refer below.

 

Your application will be sent to the companies for shortlisting and acceptance into the programme. Only shortlisted individuals will be notified by SP &/or company to attend interviews*. Trainees who are successfully enrolled into programme are to sign a training deed with SP. In addition, shortlisted trainees are required to undergo and clear medical check-up.

*Even though you may meet the minimum entry requirements and are eligible for this programme, this does not guarantee that you will be granted an interview as the companies have the discretion in the selection process.




Trainee Support*

Monthly training allowance (up to $3,600 or $2560 depending on academic qualifications).


No course fees is payable by trainees.


*Terms and Conditions Apply




Assumed Skills and Knowledge

Nil.




Minimum Entry Requirements

At least a NITEC / Higher NITEC / Diploma / Degree from any disciplines.




Outline of Facilitated WSQ Trainings at SP

Consists of eleven WSQ modules.
Trainees will complete all the eleven WSQ modules successfully to be awarded WSQ Higher Certificate in Process Technology (Biologics Manufacturing) by SP.

The eleven WSQ modules are:

i) Follow Good Manufacturing Practices
ii) Apply Safety in Process Plant
iii) Apply Continuous Process Improvement Techniques
iv) Apply Process Quality Control Techniques
v) Perform Emergency Shutdown of Process Plant
vi) Operate Inoculation and Fermentation Reactors
vii) Apply cGMP Requirements in the Workplace
viii) Operate in a Controlled Clean Room Environment
ix) Operate Tangential Flow Filtration Process Equipment
x) Operate Chromatography Process Equipment
xi) Operate Single-use Technologies




Application Procedure for AnT-Biologics Mfg

BOOST application flow

 




Application Form

Download Form




Submission of Application either:  

(1) By email
 
Email duly completed application form and supporting documents to pharma_biologics@sp.edu.sg and indicate in the title of your email ‘AnT Biologics-May 2019 Intake’.


OR

(2) By post

Send duly completed application form and supporting documents to:

Programme Manager, AnT-Biologics Manufacturing Programme
Singapore Polytechnic
School of Chemical and Life Sciences
500 Dover Road Singapore 139651
(Attention: Dr Chong Fui Chin)

Indicate on the envelope ‘AnT Biologics-May 2019 Intake’.

For further enquiries, you can send email to:

pharma_biologics@sp.edu.sg and indicate 'AnT-Biologics Mfg'