Key Responsibilities: 

• Samples clean steam samples, RO water samples, pretreatment water samples, water for injection.
• The position requires the individual to gown appropriately to the respective production rooms including aseptic gowning.
• Perform environmental monitoring of the controlled production rooms, i.e., air sample monitoring, surface monitoring, non-viable particle counts.
• Perform personnel monitoring of production operators using contact plates; this requires coordination with production personnel.
• Reading plates if needed.
• Perform environmental monitoring of aseptic filling operations (class 100).
• Train personnel on aseptic gowning and aseptic behaviour.
• Document work in master production records, logbooks, data sheets, as applicable.
• Participate and write environmental notifications and deviation investigations, as applicable.
• Prepare and revise standard operating procedures.
• Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
• Perform Line clearance and Line release for compounding and filling.
• Train personnel for tasks mentioned above.
• Any other duties as assigned.

Role Requirements:

• Minimum of 2-3 years experience in Manufacturing environment, preferably in a pharmaceutical or food industry.
• Familiar with cGMPs
• Associate Degree in Science (Biology, Microbiology or related science)
• Good aseptic techniques, documentation skills, computer skills and technical writing skills
• Self directed individual
• Must be able to build collaborative relationships with other departments including production, quality control and validation.
• Good time management skills. Must be able to handle competing priorities.
• Strong verbal and writing skills in English