Senior/biotechnologist 1

Vaccines help protect people from infectious diseases at every stage of life and our portfolio of marketed vaccines is the broadest in the industry.

Our vaccines facility at Tuas is a key manufacturing site within our global network supplying the active ingredients used to make multiple pediatric vaccines. Tuas site was officially opened in 2009. To date, the site has played a key role in producing more than 800 million vaccines for pneumococcal diseases. Tuas has a workforce of more than 300 employees.

As a Biotechnologist in our Value Stream, you will participate in the preparation, operation and completion of assigned process stages to ensure the production of bulk drug substances is within establish timing and quality standards. You will also ensure good housekeeping of the facilities to keep them in good operational order in line with cGMP, safety and environmental requirements.

**Key Responsibilities**:
**Operation**
- Adhere to cGMP and safety requirement
- Ensure good housekeeping of associated production facilities so that they are kept in good operational order
- Identify areas for improvement and participate in continuous improvement project to enhance operational effectiveness and efficiency of the unit
- Participate in commissioning and qualification activities as required
- Carry out other related duties as assigned by the N+1
- Assigned as in-charge by process/ operations area to provide guidance/ leadership to ensure process are completed reliably

**Planning**
- Follow the day to day planning
- Assist lead biotechnologist or shift supervisor in detail team operations planning

**Training & Development**
- Ensure that he/she is trained/qualified in the current effective LSOP and OJT in accordance to the training matrix prior to commencing operation.
- Proactively engage N+1 to discuss on personnel development and follow up on agreed development plan
- To provide guidance and support to new joiner ensuring his/her smooth transition to the new environment
- To develop oneself as a process SME
- Guide junior employees to ensure knowledge transfer for business continuity.
- Conduct classroom and on-the-job training as assigned quality
- Comply with all relevant LSOP/Batch record requirements
- Perform timely review of documentation and make necessary corrections.
- Have good quality mind-set and integrity to ensure products are manufactured with the highest quality
- Participate in deviation investigation process (Process, Environmental, Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action
- Participate in cGMP self-inspections to ensure compliance with internal LSOPs and regulatory requirements

**Reporting & Documentation**
- Ensure that batch record, checklist and logbooks are correctly recorded, cGMP complied and maintained
- Maintain clear communication with N+1 and fellow colleagues, providing clear feedback of any items pertaining to safety, quality and efficiency
- Participation in development and generation of production checklist, SOPs, validation protocols and the regular review and updates of these documents
- Perform VS review of completed documentation to ensure adherence to GDP
- To lead design / drafting of working instruction to ensure that it is user friendly to improve GDP

**Technology & Transfer**
- Participate in new technology and/or new process transfer

**Security/Safety/Environment**
- Awareness and adherence to site safety procedure.
- Ensure safe operations on the field
- Identify and report all potential safety issues (personal protection requirement, equipment protection, way of working etc).
- Ensure proper housekeeping of assigned production areas to minimize safety hazards
- Participate in Safety Inspection
- Participate in Safety Risk Assessment

**Interface with other Department/ Team**
- Coordination with department colleagues to ensure

Timely supply of materials and buffers
Calibration/maintenance activities are supported
Open communication on sampling requirements to QC department
- Establish good working relationship with QA, QC, maintenance, calibration to ensure smooth operation

**Proposals & Recommendations**
- Recommendations of improvements to process operation method, materials management, equipment upgrades, batch record standard
- **Why you?**_

**Basic Requirements/Qualifications**:

- We are looking for professionals with these required skills to achieve our goals: _
- Must be a holder of Nitec/Higher Nitec /Diploma in Biotechnology/Polytechnic/ Chemical Engineering or Life Science discipline
- Has at least 3 to 5 years' experience in biologics/chemical/pharmaceutical or food manufacturing industries is advantageous
- Experience in Aseptic Operation and Filtration Technique is preferred
- Has basic knowledge of cGMP
- Able to work in a cleanroom / sterile environment
- Must have good communication and documentation skills
- Must be able to attend required trainings and open to do routine work (such as facility cle