Job Title: Microbiology Specialist (Day Shift)
Location: Cambridge, ON (In-Office)
Position Type: Full-time regular

Shift: Day Shift, Monday - Friday (5:00AM - 1:30PM)
Vacancy Status: This role is currently vacant
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Job Summary:

Reporting to the Microbiology Supervisor, the Microbiology Specialist ensures that the Microbiology laboratory provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations in aseptic environmental monitoring and various microbial testing.  Acts as backup for the Microbiology Supervisor in their absence.

Key Role Specific Requirements:

• Ensures that microbiology testing for raw materials and finished product is completed in a timely and accurate manner to meet product manufacturing requirements for manufacture and release.

• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and meets housekeeping and cleanliness standards.
• Develops and validates testing methods used in routine analysis of incoming raw materials and finished products.
• Specialize in the Aseptic manufacturing environmental monitoring and various microbial testing and provides training and feedback to the Microbiologists and the Aseptic department as required.
• Specialize in various microbial testing such as Sterility test, BET, Bioburden, GPT, Microbial Assays and Identification.

• Assists as needed in the preparation of investigations relating to deviations in raw materials, finished products and environmental monitoring. Provides technical support in evaluating incidents and interventions during filling operations.
• Communicates to the Supervisor any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations.
• Participates in technical studies for research and development projects. Supports development of validation protocols and preparation of related reports.
• Assists validation in coordination of activities for media fills.
• Revises laboratory Standard Operating Procedures and test methods as required.
• Participates in internal and external audits as required. Acts as a subject matter expert and may assist in providing gown training for production staff
• Other duties as assigned.

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.

LEADERSHIP  is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture.  Provide motivational support, and the ability to develop and communicate goals in support of the business mission.  Provides direction with purpose and alignment to Company vision and values. 

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

DEALING WITH AMBIGUITY– The ability to be comfortable with change and uncertainty.  The ability to deal with fuzzy problems with limited data and with no clear solutions.  The ability to juggle several projects or to not bring closure to one project because of business changing needs.

Other Requirements :

Essential:

• 3-5 years of experience in a regulated Pharmaceutical industry including Quality Assurance. 
• Specializes in Aseptic environment monitoring and various microbial testing.
• BSc degree in Microbiology, Biology or related field.
• Knowledge of Aseptic Environmental monitoring, various microbial testing, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes
• Must possess apparent specialist qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
• Effective communication skills.

Compensation & Benefits:

• Competitive salary.
• 13 paid holidays.
• Competitive vacation policy effective upon hire.
• 5 paid personal care days.
• Employee Assistance Program.
• Expected Salary Range: $65k - $85k/Year

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 eight 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.

More info at www.bimedacareers.com

Equal Opportunity & Accessibility
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. We are committed to an inclusive and accessible recruitment process. We are an equal-opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario law.