Specialist, Operations, Viral

1 week ago


Charlottetown, Canada Merck Sharp & Dohme Full time

This Specialist position is within the Production Department at our Animal Health facility in Charlottetown, Prince Edward Island. The Charlottetown facility manufactures vaccines and biologics used within aquaculture farming.

Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using fermentation, tangential flow filtration, chromatography, cell culture platforms, and sterile filling.

The Charlottetown facility is part of our global Animal Health Manufacturing Division network and is a key contributor to the manufacturing of animal health products. Working within one of the manufacturing operations teams you will be expected to be able to work independently and as part of the team to contribute to the daily completion and schedule adherence of production activities.

The Viral Antigen manufacturing operation is made up of a team that performs aseptic procedures including media preparation, Bacterial inoculation and harvest, tissue culture preparation, infection, and harvest to produce antigen used within our aquaculture vaccines.

The position requires someone who can demonstrate a good attention to detail and achieve a consistent error-free execution of daily job responsibilities, be able to complete documentation using Good Documentation Practices and be able to identify opportunities for process improvement and employ basic problem-solving skills.

**Education Minimum Requirement**:

- A 2-year college diploma in a Science related discipline

**Required Experience and Skills**:

- 3+ years of experience in the Good Manufacturing Practices bio manufacturing industry.
- 3+ years of experience in production of biologics.
- Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point), SAP.
- Thorough technical understanding of quality systems and regulatory requirements.
- Experience in Aseptic clean room behaviors
- Able to follow/comply with Manufacturing Directions, Standard Operating Procedures, Company/Corporate/Regulatory Policies.
- Ability to demonstrates basic skills in effective time management to meet given deadlines.
- Experience with Cell Tissue Culture preparation, infection, cell counting, and harvest.

**Preferred Education, Experience and Skills**:

- Bachelor’s degree in a life science (e.g., Biochemistry, Chemistry, Chemical Engineering, biochemical engineering, Biology).
- Experience performing investigations and writing deviations.
- Experience using quality improvement tools and continuous improvement processes and site quality metrics.
- Intermediate mathematical skills preferred.
- Experience with Lyophilization

**Other Requirements and Information**:

- This position may have varying hours based on the needs of the business, including some weekends and overtime as required.
- Must be able to wear clean room garments and remain in clean room area for up to 3 hours at a time.
- Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
- Must be able to lift, move and maneuver small-medium sized equipment - up to 50lbs.
- Requires ability to stand for long periods of time.
- Must be able to read, write, understand, and comply with appropriate standard operating procedures.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Secondary** Language(s) Job Description**:
Ce poste de spécialiste se trouve au sein du département de production de notre installation de santé animale à Charlottetown, Île-du-Prince-Édouard. L'installation de Charlottetown fabrique des vaccins et des produits biologiques utilisés dans l'aquaculture.

En tirant parti d'un environnement d'équipe expérimenté et innovant, les technologies clés sur le site sont la production de produits biologiques utilisant la fermentation, la filtration tangentielle, la chromatographie, les plateformes de culture cellulaire et le remplissage stérile.

L'installation de Charlottetown fait partie de notre réseau mondial de la division de fabrication de santé animale et est un contributeur clé à la fabrication de produits de santé animale. Travaillant au sein de l'une des équipes d'opérations de fabrication, vous devrez être capable de travailler de manière autonome et en équipe pour contribuer à l'achèvement quotidien et au respect du calendrier des activités de production.

L'opération de fabrication d'antigènes viraux est composée d'une équipe qui effectue des procédures aseptiques, y compris la préparation de milieux, l'inoculation et la récolte bactérienne, la préparation de cultur



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