- 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
