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Biotechnologist

2 weeks ago

Singapore No deviation Pte Ltd Full time

About Nd
- Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.
- We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.
- We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost.

**Responsibilities**:

- Involve in hands-on execution of the plant operations and assist Manufacturing Associates in trouble-shooting
- Monitor and analyze processing parameters for atypical trends and improvement opportunities
- Perform solution and equipment preparation
- Stage components for autoclaving and washing
- Support in-process testing of production samples, prior experience with analytical instrument will be a plus point
- Actively support continuous improvement initiatives
- Support Safety audits
- Adhere to any applicable EHS and regulatory requirements
- Ability to follow written procedures, recognize and report malfunctions
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to interact with inspectors (internal and external)

**Requirements**:

- NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences or Bio-processing related disciplines
- Possess minimum 0 - 2 years of relevant experience in the biotechnology, pharmaceutical or petrochemical industry. Fresh graduates will be considered.
- Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation, prior experience and demonstration of cGMP knowledge is a plus
- Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem solving skills.
- Experience with Emerson DeltaV, LIMS, TrackWise
- Ability and willingness to work any shift in support of operations that may include 24/7

EA License No : 19C9587