Technician, Operations /Technicien(ne) des opérations

Job description

Job Description Summary of Position To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific Outlines of Production to meet market demands for aquaculture products. Main Responsibilities and Duties: Adhere to the principles of “safety first, quality always.” Perform sterile manipulations in both a biosafety hood and isolator. Maintain a cell line by 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, SOPs, and qualification documents for viral/Renogen operations. Complete timely SAP postings and maintain department inventory. Comply with safety requirements, cGMP, SOPs, 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 member with different manufacturing groups to provide resources as needed. Perform tasks under minimal 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 procedures for clean rooms. Clean, prepare, and sterilize items in autoclaves. Other duties as required. The position requires a medical assessment in accordance with applicable GMP regulations and site requirements. Qualifications and Experience Minimum Qualification (education, experience and/or training, required certifications): High School Diploma 1-3 years of experience in production preferred. 1-3 years of experience in aseptic techniques or cell culture experience is considered an asset. Excellent interpersonal skills, both communications and written. Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point). Thorough technical understanding of quality systems and regulatory requirements. Other Information: Must be able to work 8-hour daytime shifts, Monday to Friday (including some weekends and 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 the ability to stand or sit for long periods of time. Requires frequent ladder or stair climbing. Must be able to read, write, understand, and comply with appropriate standard operating procedures. This job posting is for an existing vacancy position. The anticipated base salary range for this position is $50,160 - $75,240 CAD. At our company, we are firmly committed to provide fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual employee salaries will be based on several factors such as relevant experience, skills & proficiency, and/or other bona fide factors relative to appropriate internal comparators. At our Company, we lead with people. This role includes eligibility to our discretionary short-term-incentive plan which fosters a pay-for-performance culture. Also, our contemporary rewards and benefit programs go beyond traditional medical plans and retirement programs, to create a flexible, inclusive workplace to support employee well-being, development and long-term success. We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers. 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. We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process. Required Skills: Analytical Problem Solving, Analytical Problem Solving, Biological Manufacturing, Cell Cultures, Chemical Hazards, Chemical Safety, Cleanroom Gowning, Computer Literacy, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Laboratory Processes, Machinery Operation, Maintenance of Cell Lines, Mammalian Cell Culture, Manufacturing Documentation, Manufacturing Quality Control, Microsoft Excel, Packaging Operations, Pharmaceutical Manufacturing, Primary Cell Culture, Production Scheduling, Regulatory Requirements, Shift Work, Standard Operating Procedure (SOP) Writing {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description: Résumé du poste Produire des produits biologiques vétérinaires conformément à un calendrier de production établi, en respectant les lignes directrices des BPF (Bonnes pratiques de fabrication - cGMP) ainsi que les protocoles de production spécifiques, afin de répondre à la demande du marché des produits destinés à l’aquaculture. Principales responsabilités et tâches Respecter les principes de « la sécurité avant tout, la qualité en tout temps ». Effectuer des manipulations stériles dans une hotte de biosécurité ainsi que dans un isolateur. Maintenir une lignée cellulaire en réalisant les changements de milieux de culture et les passages cellulaires. Utiliser et entretenir les instruments et équipements de production, tels que les pH-mètres, conductimètres, microscopes, lyophilisateurs, pompes péristaltiques et autres équipements de fabrication. Effectuer des cultures cellulaires stériles et des processus d’infection virale. Rédiger et réviser les dossiers de lots, les procédures opératoires normalisées (PON/SOP) et les documents de qualification pour les opérations virales/Renogen. Effectuer les saisies SAP en temps opportun et assurer la gestion de l’inventaire du département. Respecter les exigences en matière de sécurité, les BPF (cGMP), les SOP et l’ensemble de la documentation de fabrication. Collaborer avec les autres départements impliqués dans la fabrication sous BPF pour la planification de la production, des essais et de la libération des produits, afin d’assurer l’achèvement des projets dans les délais prévus. Travailler au sein d’équipes multidisciplinaires et fournir du soutien à différents groupes de fabrication, selon les besoins. Réaliser les tâches avec un minimum de supervision et dans le respect d’échéanciers serrés afin de répondre aux calendriers de production. Contribuer au maintien des équipements de production en bon état de fonctionnement, conformément aux spécifications des fabricants. Assurer la propreté des zones de production et appliquer les procédures de désinfection des salles propres. Nettoyer, préparer et stériliser le matériel à l’aide d’autoclaves. Effectuer toute autre tâche connexe, au besoin. Ce poste requiert une évaluation médicale conformément aux réglementations BPF applicables et aux exigences du site. Qualifications et expérience Qualifications minimales (formation, expérience et/ou certifications requises) Diplôme d’études secondaires (DES). De 1 à 3 ans d’expérience en production, un atout. De 1 à 3 ans d’expérience en techniques aseptiques ou en culture cellulaire, considéré comme un atout. Excellentes habiletés interpersonnelles, de communication orale et écrite. Maî