QC Microbiologist

JO

Biotech manufacturing

Sligo

Have you ever wondered what it is like to work in a Biotech before it goes into full scale production? Well this could just be the role for you. This company are small at present but have a massive global presence in the biotech space. Currently they are recruiting a QC Microbiologist for their facility. The successful candidate will be responsible for utility qualification, utility testing, environmental monitoring, product testing.

Role

· Understand and support testing of product samples including raw materials, intermediates and finished goods as well as environmental and clean utilities samples.

· Performance of laboratory tests as per standard operating procedures.

· Recording of analytical results accurately.

· Operation, maintenance and calibration of laboratory instruments.

· Generation or updates of necessary documentation to support the QC laboratory, i.e. procedures, work instructions and protocols.

· Execute microbiological/product method validations as needed for product and clean utilities qualification program.

· Perform bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs).

· When required, perform virus neutralization and viral titration sample analysis in accordance with standard operating procedures (SOPs).

· Perform or support the sample analysis for microbial identification.

· Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.

· Present analytical data/trend reports clearly and concisely to management.

· Sampling and testing to support qualification and re-validation of utilities and cleanrooms.

· Ensure cGMP & GLP standards are maintained and adherence to schedules to meet regulatory and business requirements.

· Support the execution of pilot scale vaccine manufacturing processes for proof-of-concept and optimization trials.

Requirements

· Honours Bachelor's degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceutical science). A Bachelor's degree in science with additional significant microbiology lab experience will be considered.

· Min 3 years of industry experience within a GMP laboratory.

· Significant microbiological skills and understanding will be considered an advantage.

· Experience with vaccines would be preferable particularly in the area of viral titrations, ELISA and PCR testing.

· Must have experience in authoring, reviewing and execution of method validation studies and reports.

· Experience in laboratory investigations, deviations and change controls will be considered an advantage.