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 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 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 studiesTo support monitoring for facility’s utilities systemsTo lead equipment qualificationTo coordinate calibration, and maintenance of laboratory equipmentTo be involved in aseptic process simulationsTo develop technical documentations such as protocols, position papers and risks assessments.To perform method transfer/verification/validation for new product introductionTo lead microbiological inventory managementTo support global initiatives such as automation and operational excellence initiativesTo maintain and review the accuracy, completeness, and compliance of laboratory dataTo maintain individual’s training recordsTo lead continuous improvement activitiesTo communicate in site and global platformsTo ensure cGMP is applied and adhered to in their area of workTo collaborate with HSE, cGMP and always maintain a 5S approachTo perform tasks required by ManagerTo 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 timesEnsure timely reporting and investigation of all accidents, near misses and breaches of rulesMinimum Requirements/Qualifications:Degree in Microbiology, Biology or strongly related scientific field with minimum experience of 3 years in the laboratoryExperience in microbiological techniques such as bioburden testing, endotoxin testing, environmental monitoring, growth promotion testing, and identification of microorganisms.Basic proficiencies in Microsoft Words, Excel, PowerPointKnowledge in FDA/EMA/HSA/Global regulatory requirements applicable to microbiology and environmental monitoring in biologics.Ability to work independently and follow critical timelinesAdaptable to a changing work environmentEffective interpersonal attributes at all internal and external levels.Excellent attention to detail.Developed time management and project management skillsSelf motivated individual and excellent problem solving skills