Reporting to the QC Manager, the Microbiologist is responsible for microbiological testing to support the production facility and ensuring that all work provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations.

Key Role Specifications

• 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

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. 

Competencies Required for the Role

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance.  Respects others.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people.  It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts.  Exhibit willingness to listen, and show respect for oneself and others in interactions with others.   express oneself clearly in verbal and business writing.

ATTENDANCE/PUNCTUALITY– Meeting expectations requires that the employee regularly reports for work on time, prepared to start his/her assigned duties at the appointed time.  Report-for-duty time is defined as readiness to perform the first assigned task at the scheduled start of a shift and employee does not leave assigned post early, works through the end of work hours.    Employee leaves and returns from scheduled breaks and lunch at designated times.

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach.  Ability to identify and separate the key components of problems and situations.  Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. 

THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

Other Requirements:

Essential

• 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

About Bimeda

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 optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers 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 commercialization 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.

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More Info at www.bimedacareers.com