- The position requires the individual to gown appropriately to the respective production rooms including aseptic gowning.
- Perform testing of WFI, Clean Steam, Air samples, pre-treatment water, Raw Materials, In-process, Finished Product and Stability Samples.
- Environmental Monitoring of Sterility Assurance Laboratory, Laminar Flow Hoods in Microbiology and Media Preparation laboratories.
- Evaluation of Environmental Monitoring Testing media plates of controlled rooms and environment.
- Identification of isolates from control rooms, raw materials, in-process samples, finished product samples, stability samples.
- Preparation and Testing of Media including growth promotion.
- Release and Testing Biological Indicators to support Validation activities.
- Document work in master production records, logbooks, data sheets, as applicable.
- Prepare and revise standard operating procedures.
- Perform out-of-specification investigations, environmental excursion investigations and deviations per company procedures
- The job responsibilities require the ability to lift, push, pull and carry up to 50 pounds; it requires a combination of walking around the facility along with sedentary work.
- Support continuous improvement program throughout the company.
- Accurately document all data in compliance with GMP.
- Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
- Develop and validate testing methods used in routine analysis of incoming raw materials and finished products (i.e. LAL, Endotoxin, Sterility, Bioburden)
- Provide technical support in the area of microbiology to the Manufacturing and Validation departments.
- Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
- Interface with FDA compliance officers during facility inspections.
- Trend Analysis, Other special projects (i.e. Disinfectant Efficacy study)
- Write environmental reports and presenting the data during environmental meetings.
- Train personnel on microbiology related topics.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com