Microbiologist II

Full Time, onsite
Thermo Fisher Scientific
Singapore, Singapore

Salary undisclosed

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Work Schedule Standard (Mon-Fri)Environmental 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, 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 DescriptionThermo 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 sophisticated 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, SGThe 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 lead equipment qualification
To coordinate calibration, and maintenance of laboratory equipment
To be involved in aseptic process simulations
To develop technical documentations such as protocols, position papers and risks assessments.
To perform method transfer/verification/validation for new product introduction
To lead microbiological inventory management
To support global initiatives such as automation and operational excellence initiatives
To maintain and review the accuracy, completeness, and compliance of laboratory data
To maintain individual’s training records
To lead 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 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 of rules

Minimum Requirements/Qualifications:

Degree in Microbiology, Biology or strongly related scientific field with minimum experience of 3 years in the laboratory
Experience in microbiological techniques such as bioburden testing, endotoxin testing, environmental monitoring, growth promotion testing, and identification of microorganisms.
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.
Developed time management and project management skills
Self motivated individual and excellent problem solving skills

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 lead equipment qualification
To coordinate calibration, and maintenance of laboratory equipment
To be involved in aseptic process simulations
To develop technical documentations such as protocols, position papers and risks assessments.
To perform method transfer/verification/validation for new product introduction
To lead microbiological inventory management
To support global initiatives such as automation and operational excellence initiatives
To maintain and review the accuracy, completeness, and compliance of laboratory data
To maintain individual’s training records
To lead 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 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 of rules

Minimum Requirements/Qualifications:

Degree in Microbiology, Biology or strongly related scientific field with minimum experience of 3 years in the laboratory
Experience in microbiological techniques such as bioburden testing, endotoxin testing, environmental monitoring, growth promotion testing, and identification of microorganisms.
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.
Developed time management and project management skills
Self motivated individual and excellent problem solving skills