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Production Technician, Fermentation

2 months ago

Charlottetown, Canada Merck Full time

Job Description

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.

Functions, Duties, Tasks:

  • Comply with safety requirements, cGMP, SOP, and manufacturing documentation.

  • Produce antigens in a timely manner according to their approved Outline of Production/Product Dossiers and to cGMP guidelines.

  • Support Antigen production and freeze-dried vaccines production according to standard operating procedures and protocols.

  • Complete environmental monitoring, both viable and non-viable monitoring.

  • Prepare materials for production needs.

  • Organizing, labeling, wrapping and sterilization of materials.

  • Ensure equipment and materials are in state of readiness for production technicians.

  • Cleaning/disinfection of production areas and materials as outlined in specific standard operating procedures.

  • Assist in buffer preparation and other supporting activities related to down streaming process.

  • Perform routine activities such as recording temperatures and room pressures, performing purified water sampling and clean steam sampling.

  • Support fermentation operator by cleaning fermenters and associated parts, set up/tear down of fermenters.

  • Preparation and modification of standard operating procedures as required.

  • Other duties as required.

Minimum Qualifications (education, experience and/or training, required certifications):

  • High School Diploma or equivalent.

  • Basic computer skills including experience with Windows Operating System and Microsoft Office products. 

  • Proficient reading, comprehension, and application skills toward a diverse set of complicated tasks.

  • Ability to accurately perform calculation, analyze, and processes scientific data.

  • Strong verbal and written communication skills. Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.

  • Demonstrated success working in a team environment.

  • Demonstrated ability and understanding of safe working habits.

  • Ability to work flexible hours as necessary to meet production demands and timelines.

  • Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.

Additional Preferences:

  • Bachelor’s degree and/or Biotechnology Diploma (or equivalent) in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.).

  • 2+ years’ experience in a regulated, commercial GMP biomanufacturing  environment (relevant experience may include: media and buffer preparation, and fermentation).

  • Innovative spirit, strong initiative and work ethic, and positive attitude.

  • Able to follow written instructions and provide detailed documentation of work performed

  • Good mechanical aptitude.

  • Experience in the preparation of standard operating procedures, preparation of batch records as per specific GMP requirements.

  • Experience performing investigations and writing deviations.

  • Thorough technical understanding of quality systems and regulatory requirements.

  • Language requirement : English

Other Information:

  • 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 25lbs.

  • Requires ability to stand 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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Pour produire des biologiques vétérinaires selon un calendrier de production défini, suivant les directives cGMP et des lignes directrices spécifiques de production afin de répondre aux demandes du marché pour les produits aquacoles.

Fonctions, tâches, responsabilités:

  • Respecter les exigences en matière de sécurité, les directives cGMP, les procédures opérationnelles standard (SOP) et la documentation de fabrication.

  • Produire des antigènes en temps opportun conformément à leur Plan de production approuvé / Dossiers de produits et aux directives cGMP.

  • Soutenir la production des antigènes et des vaccins lyophilisés selon les procédures opérationnelles standard et les protocoles. Effectuer une surveillance environnementale complète, tant viable que non viable.

  • Préparer les matériaux pour les besoins de production.

  • Organiser, étiqueter, emballer et stériliser les matériaux.

  • Veiller à ce que l'équipement et les matériaux soient prêts pour les techniciens de production.

  • Nettoyage / désinfection des zones de production et des matériaux conformément aux procédures opérationnelles standard spécifiques.

  • Aider à la préparation des tampons et autres activités de soutien liées au processus d'aval.

  • Effectuer des activités de routine telles que l'enregistrement des températures et des pressions des salles, le prélèvement d'eau purifiée et d'échantillons de vapeur propre.

  • Soutenir l'opérateur de fermentation en nettoyant les fermenteurs et les pièces associées, en installant / démontant les fermenteurs. Préparation et modification des procédures opérationnelles standard au besoin. Autres tâches requises.

Qualifications minimales (éducation, expérience et/ou formation, certifications requises) :

  • Diplôme d'études secondaires ou l'équivalent.

  • Compétences de base en informatique, y compris une expérience avec le système d'exploitation Windows et les produits Microsoft Office.

  • Compétences en lecture, compréhension et application efficaces pour un ensemble diversifié de tâches complexes.

  • Capacité à effectuer avec précision des calculs, à analyser et à traiter des données scientifiques. Solides compétences en communication verbale et écrite.

  • Doit être hautement motivé, suivre des instructions orales et écrites, communiquer efficacement, penser logiquement et s’épanouir de manière indépendante et/ou dans un environnement d'équipe rapide. Succès démontré dans le travail d'équipe.

  • Capacités démontrées et compréhension des bonnes habitudes de travail en toute sécurité.

  • Capacité à travailler des heures flexibles si nécessaire pour répondre aux exigences et aux délais de production.

  • Doit être capable de porter une tenue appropriée et un équipement de protection individuelle (EPI) dans les zones de production et de soutien à la fabrication.

Préférences supplémentaires:

  • Diplôme universitaire et/ou diplôme en biotechnologie (ou équivalent) dans une discipline liée à la bioproduction (par exemple, biologie, chimie, ingénierie, etc.).

  • 2 ans d’expérience dans un environnement de bioproduction GMP réglementé, commercial (l'expérience pertinente peut inclure : la préparation de milieux et de tampons, et la fermentation).

  • Esprit innovant, forte initiative et éthique de travail, et attitude positive.

  • Capable de suivre des instructions écrites et de fournir une documentation détaillée du travail effectué. Bonne aptitude mécanique.

  • Expérience dans la rédaction de procédures opérationnelles standard, la préparation de dossiers de lots selon des exigences GMP spécifiques.

  • Expérience dans la réalisation d'investigations et la rédaction de déviations. Compréhension technique approfondie des systèmes qualité et des exigences réglementaires.

  • Language requirement: Eng

Autres informations:

  • Doit être capable de porter des vêtements de salle blanche et de rester dans la zone de salle blanche jusqu'à 3 heures à la fois.

  • Doit aider aux procédures de désinfection impliquant des produits chimiques dangereux nécessitant l'utilisation d'un respirateur.

  • Doit être capable de soulever, déplacer et manœuvrer des équipements de petite à moyenne taille - jusqu'à 25 lb.

  • Nécessite la capacité de rester debout pendant de longues périodes. Nécessite une montée fréquente d'échelles ou d'escaliers.

  • Doit être capable de lire, écrire, comprendre et respecter les procédures opérationnelles standard appropriées.

Nous sommes fiers d'être une entreprise qui embrasse la valeur de rassembler des personnes diversifiées, talentueuses et engagées. La façon la plus rapide d’innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collègues à remettre en question avec respect les problèmes de réflexion et d’approche de l’un et de l’autre. Nous sommes un employeur souscrivant au principe de l’égalité d’accès à l’emploi et nous sommes déterminés à favoriser un milieu de travail inclusif et diversifié.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Yes

Job Posting End Date:

09/9/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:09/09/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R307659