Work Schedule
OtherEnvironmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Pharma Services Group (PSG) - Singapore, SG
The Microbiologist II position is an integral member of the Quality Control (Microbiology) team. In this role you will perform work required to ensure product quality is maintained at standards set forth by the Pharma Services Group (PSG), part of Thermo Fisher Scientific’s Quality System and mandated by regulatory agencies. Responsibilities include utilities/cleanroom monitoring, completing incoming, in-process, and final release testing of various products manufactured or received by PSG, part of Thermo Fisher Scientific.
Key Responsibilities:
- To perform quality control microbiological testing of raw materials, incoming goods, intermediates, and/or finished products under cGMP conditions for QC release or as part of stability studies
- To support monitoring for facility’s utilities systems
- To support equipment qualification
- To perform and coordinate calibration, and maintenance of laboratory equipment
- To be involved in aseptic process simulations
- To support method transfer/verification/validation for new product introduction
- To perform periodic reviews for laboratory documents
- To lead microbiological inventory management
- To maintain the accuracy, completeness, and compliance of laboratory data
- To maintain individual’s training records
- To support continuous improvement activities
- To communicate in site and global platforms
- To ensure cGMP is applied and adhered to in their area of work
- To collaborate with HSE, cGMP and always maintain a 5S approach
- To perform tasks required by the Manager
- To support shift work (when required)
EH&S:
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
- Ensure timely reporting and investigation of all accidents, near misses and breaches
Minimum Requirements/Qualifications:
- Degree in Microbiology, Biology or strongly related scientific field with minimum 2 years of laboratory experience
- Experience in basic microbiological techniques e.g. bioburden testing, endotoxin testing, and, environmental monitoring
- Basic proficiencies in Microsoft Words, Excel, PowerPoint
- Knowledge in FDA/EMA/HSA/Global regulatory requirements applicable to microbiology and environmental monitoring in biologics.
- Ability to work independently and follow critical timelines
- Adaptable to a changing work environment
- Effective interpersonal attributes at all internal and external levels.
- Excellent attention to detail.
- Good time management and project management skills
- Self motivated individual
