- Performs Sterility testing, bioburden testing, EM data, growth promotion, microbial ID, Particulate Matter testing, BET and other microbiological tests.
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs)
- Develops and validates testing methods used in routine analysis of incoming raw materials and finished products
- Performs water sampling and microbial testing of water for injection, purified water, steam condensate and feed water as per schedule
- Reads plates and reports the results of microbial tests including identification of isolates selected from the monitoring results
- Prepares microbiological media and performs growth promotion test on both in house and purchased media
- Prepares, sterilizes and sanitizes equipment and facilities used in the conduct of microbial testing, including the sterility-testing suite and environmental monitoring
- Provides technical support in the area of Microbiology to the Manufacturing and Validation departments
- Participates in internal and external audits as required. Acts as a subject matter expert and may assist in providing gown training for production staff
- Follows GMP and regulatory requirements and ensures quality standards are met. Observes and supports all safety guidelines and regulations
- Assists Lead microbiologist in writing validation protocols, project reports, updating laboratory documentation, SOPs and test methods
- Other duties as assigned
- BSc degree in Microbiology
- 1-2 years industry experience in pharmacopoeia testing, sterilization validation and general pharmaceutical microbiology laboratory
- Knowledge of, cGMP in pharmaceutical manufacturing
- Knowledge of microbiology (industrial), environmental and utility monitoring and aseptic processing
- Experience with sterility testing, endotoxin assays and validation, microbiological limits testing, knowledge of USP and EP/BP method/validation regulations, Microbiological identification methods
- The position works mainly in a controlled office environment but may require periodically working in the laboratory and or production areas
- Preparation of written reports may involve long periods of sitting in front of a computer typing or entering data.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager
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