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An established industry player in scientific services is seeking a Senior Microbiologist to join their Quality Control team. This role offers a unique opportunity to ensure product quality through rigorous microbiological testing and compliance with cGMP standards. The successful candidate will lead investigations, manage laboratory equipment, and mentor peers while working in a dynamic environment. If you're passionate about maintaining the highest standards in laboratory practices and thrive in a collaborative setting, this position could be your next career milestone.
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, Laboratory Setting, Loud Noises (Equipment/Machinery), 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.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials, Working at heights
Job 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, SG
The Senior Microbiologist 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. This role is a technical lead in microbiology and involved in utilities/cleanroom monitoring, 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 lab and microbiological investigations at the site
To lead new equipment qualification
To coordinate calibration, and maintenance of laboratory equipment
To be involved in aseptic process simulations
To develop protocols, position papers and risks assessments.
To lead and perform method transfer/verification/validation
To lead microbiological inventory management
To lead global initiatives such as automation and business improvement initiatives
To mentor peers in technical aspects of microbiology.
To support site and/or global audits and inspections.
To maintain and review the accuracy, completeness, and compliance of laboratory data
To maintain individual’s training records
To lead laboratory continuous improvement activities
To communicate in site and global platforms
To ensure cGMP is applied and complied 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 5 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, Power Point
Knowledge in FDA/EMA/HSA/Global regulatory requirements applicable to microbiology and environmental monitoring
Ability to work independently with good time management to align with critical timelines
Adaptable to a changing work environment
Effective interpersonal attributes at all internal and external levels.
Excellent attention to detail
Self motivated individual and excellent problem solving skills