Production Technician, Viral

2 months ago

Charlottetown, Canada Merck Canada Inc. Full time

Job Description
To produce veterinary biologics according to a defined production schedule following cGood Manufacting Practices (GMP) guidelines and specific Outlines of Production to meet market demands for aquaculture products.
**Functions, Duties, Tasks**:
Adhere to the principles of "safety first, quality always".
Perform sterile manipulations in both a biosafety hood and isolator.
Maintain a cell line completing media changes and cell passages.
Operate and maintain production instruments and equipment, such as pH meters, conductivity meters, microscopes, lyophilized, peristaltic pumps and other production equipment.
Perform sterile cell culture and viral infection processes.
Write and review batch records, Standard Operating Procedures, qualification documents for viral operations.
Complete timely SAP postings and maintain department inventory.
Comply with safety requirements, cGMP, Standard Operating Procedures, and manufacturing documentation.
Collaborate with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
Work as a cross functional team with different manufacturing groups to provide resources as needed.
Perform tasks under mínimal supervision, and within tight timelines to meet production schedules.
Assist in maintaining production equipment in good condition as per manufacturer's specifications.
Maintain the cleanliness of the production areas and follow disinfection procedure of clean rooms.
Responsibilities include cleaning, preparing and sterilizing items in autoclaves.
Other duties as required.
Minimum Qualifications (education, experience and/or training, required certifications):
A 2-year biotechnology diploma is required; a Bachelor's degree or Post-Secondary education in a life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.
3-5 years of pharmaceutical/biological manufacturing experience in GMP environment is preferred.
3-5 years of experience in aseptic techniques or cell culture experience is preferred.
Excellent interpersonal skills, both communications and written.
Outlines of Production, cGMP guidelines, and Health, Safety & Environment regulations.
Experience performing investigations and writing deviations.
Intermediate/Expert computer skills using Microsoft Office (Word, Excel, Power Point).
Thorough technical understanding of quality systems and regulatory requirements.
**Other Information**:
8-hour daytime shifts Monday to Friday with overtime as required.
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 and raw materials - up to 50lbs.
Requires ability to stand or sit 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.
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays and vacation.
**Secondary Language(s) Job Description**:
Produire des produits biologiques vétérinaires selon un calendrier de production défini en suivant les directives Bonnes pratiques de fabrication (BPF) et les plans de production spécifiques pour répondre aux demandes du marché en matière de produits aquacoles.
**Fonctions, devoirs, tâches**:
Adhérer aux principes de " la sécurité d'abord, la qualité toujours ".
Effectuer des manipulations stériles sous une hotte de biosécurité et un isolateur.
Entretenir une lignée cellulaire en effectuant les changements de milieu et les passages de cellules.
Utiliser et entretenir les instruments et l'équipement de production, tels que les pH-mètres, les conductimètres, les microscopes, les pompes lyophilisées, péristaltiques et autres équipements de production.
Effectuer des processus de culture cellulaire stérile et d'infection virale.
Rédiger et réviser les dossiers de lots, les procédures d'opération normalisées, les documents de qualification pour les opérations virales.
Compléter les écritures SAP en temps opportun et tenir à jour l'inventaire du service.
Se conformer aux exigences de sécurité, aux Bonnes pratiques de fabrication (BPF), aux procédures d'opérations normalisées et à la documentation de fabrication.
Collaborer avec d'autres services impliqués dans la fabrication BPF pour planifier la production, les te

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