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
• Evaluate documentation/data according to company and regulatory guidelines
• Engage & interact with inspectors (internal and external)
• Interpretation and application Good Manufacturing Practice (GMP) knowledge is required
• Basic statistical mathematical skills
• Ability to organize work and handle multiple priorities and meet deadlines
• Need to understand, apply and evaluate basic chemistry, biology and physical principles
• Understanding of analytical methods
Basic Qualification
- Diploma in Science or Engineering
Preferred Qualification
• 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.
• Proficiency in reading and writing English
• 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
• Excellent self-motivated team player with hands-on attitude and good communication skills
• Experience with Emerson DeltaV, LIMS, TrackWise
• Should understand, apply and evaluate basic chemistry, biology and physical principles
• Required to work any shift in support of operations that may include 24/7
• Mechanical ability/expertise