Microbiologist I

Work Schedule

12 hr shift/days

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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Work Hours/Shift Information: This role will initially follow normal working hours (8:00 AM - 5:15 PM) for training and may require occasional support for night testing. Once ready, you will transition to a rotating 24x5 shift pattern , and eventually to a 24x7 shift pattern depending on operational needs.

Location

31 Joo Koon Circle, Singapore

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

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 1-2 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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