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Location
1675 Rte Transcanadienne, #135
Dorval, QC – Canada H9P 1J1

Phone+1 (514) 339-5986
Fax+1 (514 ) 375-1360

Emailinfo@capcium.com

Be Part of Our Team

With the rapidly evolving nature of our industry, we are always on the look-out for talented people to join our dynamic team and help us achieve our goals.

Check out our job postings below, or feel free to send us your resume at careers@capcium.com.

Validation Specialist

Version française ci-dessous /French version below

Overview

Capcium is seeking a results-driven individual to join the team as a Validation Specialist who will be responsible for carrying out validation/qualification activities for production and Laboratory equipment (i.e steam sterilizer, incubator), systems, utilities, process and cleaning at Capcium. Reporting to the Validation Manager, the Specialist will need to ensure that all stages of the project are conducted in accordance with standard procedures (Health and Safety, Good Manufacturing Practices, etc.). He/She will coordinate the activities of all parties involved: professionals, contractors, consultants, and serve as a link to internal customers and also review and approve documents (protocols and reports). The mandate also includes validation change management.

Main Responsibilities

  • Participate in the development of validation/qualification strategies
  • Draft and execute qualification protocols (IQ, OQ, and PQ when relevant) as well as process and cleaning method validation
  • Write deviations that occur during validation/qualification and recommend corrective actions
  • Drafting and approval of validation protocols and reports (process and Cleaning)
  • Write qualification (IQ, OQ, and PQ if applicable) and validation (process and cleaning) reports
  • Plan and execute qualification/validation protocols within the expected timelines
  • Assist and coordinate external suppliers on site for validation activities.
  • Write SOPs and validation protocols in accordance with corporate standards and current GMPs
  • Participate in the resolution of gaps, investigations, and deficiencies
  • Change management validation
  • Participate in the drafting/revision of the Validation Master Plan (VMP)
  • Maintain validation/qualification documentation and archiving by ensuring efficient document retrieval, when requested
  • Support the engineering team during the selection of new equipment, equipment startup (FAT and/or SAT).

Qualifications and Experience

  • Bachelor’s degree in Engineering (Chemistry or Mechanics) or Science: Chemistry, Biology, Biochemistry
  • Minimum of 3 years of experience in validation in the pharmaceutical industry
  • Experience in the qualification of equipment used in manufacturing and/or packaging of various dosage forms as well as critical systems (HVAC, purified water, compressed air)
  • Experience in validation of cleaning methods and manufacturing processes.
  • Knowledge of use of Kaye Validator
  • Excellent working knowledge of cGMP requirements on validation methods and including ISPE, GAMP and FDA principles, CFR Part 11 (requirements for electronic records and signatures)
  • Capable of developing and writing applicable validation documentation, including but not limited to URS, DOE, FAT, IQ, OQ
  • Experience in project management would be an asset

Knowledge and Abilities

  • Bilingual: French and English spoken and written
  • Capable of managing multiple complex projects and working independently
  • Ability to review and approve technical reports effectively
  • Ability to write technical reports clearly and accurately
  • Can work under pressure and adaptation to changes
  • Good sense of communications and emergencies (prioritization)
  • Multifunctional teamwork
  • Proficient in computer tools like Microsoft Office, Outlook, MS Project.
  • Office and factory work
  • Travel to production sites may be required

Apply for this job

 

Spécialiste Validation

Sommaire du poste

En tant que Spécialiste Validation, vous serez responsable de réaliser les activités de validation pour les équipements, systèmes, utilités, informatique, procédé et nettoyage chez Capcium.  Vous devrez vous assurer que toutes les étapes du projet soient effectuées conformément aux procédures normalisées (Santé et sécurité, Bonnes pratiques de fabrication, etc.). Vous aurez à coordonner les activités de toutes les parties impliquées : professionnels, entrepreneurs, consultants, et servir de lien avec les clients internes. Vous procéderez également à la révision et à l’approbation des documents (protocoles et rapports).

Le Spécialiste Validation se rapportera au Chef Validation.

Responsabilités clés

  • Rédaction et approbation des protocoles de validation et des rapports (QI, QO et PQ le cas échéant)
  • Planification et exécution des protocoles de qualification / validation dans les délais prévus
  • Qualification des équipements de production et des instruments de laboratoire (autoclave)
  • Qualification des systèmes, utilitaires et informatique (réseau/infrastructure et logiciels)
  • Validation de processus et validation de nettoyage
  • Assister et coordonner les fournisseurs externes sur site pour les activités de validation
  • Rédiger des SOP et des protocoles de validation conformément aux normes de l’entreprise et aux BPF en vigueur
  • Participer à la résolution des problèmes des enquêtes et des déficiences

Compétences et expérience

  • Baccalauréat en Génie (Chimie ou Mécanique) ou en sciences : Chimie, Biologie, Biochimie
  • Minimum de 3 ans d’expérience en validation dans l’industrie pharmaceutique
  • Expérience dans la qualification des équipements utilisés en fabrication et/ou emballage de diverses formes posologique ainsi que des systèmes critiques (HVAC, eau purifiée, air comprimé)
  • Excellente connaissance pratique des exigences cGMP sur les méthodes de validation et y compris les principes ISPE, GAMP et FDA, CFR Part 11 (exigences relatives aux enregistrements et signatures électroniques)
  • Capable d’élaborer et de rédiger la documentation de validation applicable, y compris, mais sans s’y limiter, les URS, DOE, FAT, IQ, OQ
  • Une expérience en gestion de projets serait un atout

Habilité, connaisance et aptitudes

  • Bilingue : français et anglais à l’oral et à l’écrit;
  • Capable de gérer plusieurs projets complexes et de travailler de manière autonome
  • Aptitude à revoir et approuver efficacement les rapports techniques
  • Aptitude à rédiger des rapports techniques de manière claire et précise
  • Gestion de la pression et adaptation aux changements
  • Bon sens des communications et des urgences (priorisation)
  • Travail en équipe multifonctionnelle
  • Maîtrise des outils informatiques comme Microsoft Office, Outlook, MS Project.
  • Travail de bureau et en usine
  • Déplacement sur les sites de production peuvent être requis

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Validation Specialist (IT)

Version française ci-dessous /French version below

Overview

As a Computer System Validation Specialist, you will be responsible for carrying out validation activities at Capcium on computerized systems for equipment, systems, utilities that have GxP impact for ensuring compliance with 21CFR11 requirements. Reporting to the Validation Manager, you will be responsible to ensure that all stages of the project are conducted in accordance with standard procedures (Health and Safety, Good Manufacturing Practices, etc.) and to the GAMP5 Validation Life Cycle. You will coordinate the activities of all parties involved: professionals, contractors, consultants, and serve as a link to internal customers.  Furthermore, the Specialist will also need to author, review and approve documents.

Key Responsibilities

  • Review and/or assist in developing validation strategies and associated documentation as well as the validation master plan (VMP) to ensure that compliance and business need are achieved;
  • Qualification of systems, utilities and IT (network and software);
  • Prepare and approve validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects;
  • Participate in periodic review of computer systems, data integrity assessment of the systems, and audit trail review;
  • Planning and execution of qualification/validation protocols within the expected timelines;
  • Analyze and perform assessments using a risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security, and assign appropriate levels of validation accordingly;
  • Assist and coordinate external suppliers on-site for validation activities;
  • Write SOPs and validation protocols in accordance with corporate standards and current GMPs;
  • Participate in the resolution of gaps, investigations, and deficiencies;
  • Maintain computer system validation documentation and archiving ensuring effective document retrieval when required;

Qualifications and Experience

  • Bachelor’s degree in the field of computer sciences (e.g. IT, Information security e, Engineering, software programming, etc.)  or equivalent combination of experience and education.
  • Minimum of 3 years of experience in validation of GxP computerized system in the pharmaceutical industry
  • Experienced in executing test cases, test scripts and documenting test results for computerized systems and automation platforms.
  • Experience computerized system validations methodologies, 21 CFR Part 11, and Data Integrity regulations.
  • In-depth knowledge and understanding of computer system validation processes and regulatory requirements, including FDA guidelines and cGMPs relevant to 21 CFR Part 11 compliance requirements and ISPE/GAMP 5 guidelines.
  • Knowledge of Industry guidelines, US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments., standard Operating Procedures, validation requirements, and computerized systems required
  • Experience with any of the following: Computer Systems Validation / QA within FDA (GxP) regulated environments; automated testing tools, validation and qualification of various IT systems used in manufacturing environments; development of full validation documentation and testing protocols (IQ/OQ/PQ).
  • Capable of developing and writing applicable validation documentation, including but not limited to URS, DOE, FAT, IQ, OQ
  • Experience in project management would be an asset

Knowledge and Abilities

  • Bilingual: French and English spoken and written (required)
  • Capable of managing multiple complex projects and working independently
  • Ability to review and approve technical reports effectively
  • Ability to write technical reports clearly and accurately
  • Can work under pressure and adaptation to changes
  • Good sense of communications and emergencies (prioritization)
  • Multifunctional teamwork
  • Proficient in computer tools like Microsoft Office, Outlook, MS Project.
  • Office and factory work
  • Travel to production sites may be required

Apply for this job

 

Coordinateur Qualité aux procédures

Sommaire du poste

En tant que spécialiste en validation de systèmes informatiques, vous serez responsable de réaliser les activités de validation chez Capcium sur des systèmes informatiques reliés aux équipements, systèmes et utilités ayant un impact GxP dans le but de s’assurer de la conformité aux exigences de la norme 21CFR11. Rapportant au Chef Validation, vous devrez vous assurer que toutes les étapes du projet sont conduites conformément aux procédures standard (Santé et sécurité, Bonnes pratiques de fabrication, etc.) et au GAMP5 (GAMP5 validation life cycle). Vous coordonnerez les activités de toutes les parties impliquées : professionnels, entrepreneurs, consultants et ferez le lien avec les clients internes. Vous pourrez également créer, examiner et approuver des documents liés à vos tâches.

Responsabilités clés

  • Qualification des systèmes, utilités et TI (infrastructure et logiciels)
  • Examiner et / ou aider à élaborer des stratégies de validation et la documentation associée, ainsi que le plan directeur de validation (VMP), afin de garantir la conformité et les besoins opérationnels.
  • Préparer et approuver le package de documentation de validation, incluant le développement et l’exécution de la documentation pour les activités de validation et de qualification de divers projets de validation de systèmes informatiques. Les documents peuvent inclure: la rédaction et l’approbation du plan de validation, des protocoles et des rapports de validation, les spécifications des utilisateurs, la matrice de traçabilité , les spécifications de fonctionnement et de conception, les protocoles de test (IQ/OQ/PQ), les tests d’acceptation des utilisateurs, les rapports de validation, les procédures opératoires normalisées, la documentation de contrôle des changements et l’évaluation des risques.
  • Participer à l’examen périodique des systèmes informatiques, à l’évaluation de l’intégrité des données des systèmes et à la révision de la piste de vérification.
  • Planification et exécution des protocoles de qualification / validation dans les délais prévus.
  • Analyser et effectuer des évaluations en utilisant une approche basée sur le risque pour les changements apportés aux systèmes informatisés validés ayant un impact sur  l’intégrité des données, le réseau et la sécurité. À l’issue de l’évaluation attribuer le niveau de validation approprié.
  • Assister et coordonner les fournisseurs externes sur site pour les activités de validation
  • Rédiger des SOP et des protocoles de validation conformément aux normes de l’entreprise et aux BPF en vigueur.
  • Participer à la résolution de problèmes, investigations enquêtes et déficiences.
  • Maintenir la documentation de validation des systèmes informatiques et l’archivage en assurant une récupération efficace des documents, le cas échéant.

Compétences et expérience

  • Baccalauréat dans le domaine des sciences informatiques (informatique, sécurité de l’information, ingénierie, programmation de logiciels, etc.) ou combinaison équivalente d’expériences et de formation. Minimum de 3 ans d’expérience en validation de systèmes informatisés GxP dans l’industrie pharmaceutique : Expérience dans l’exécution de scénarios de tests, de scripts de tests et la documentation de résultats de tests pour des systèmes informatisés et des plates-formes d’automatisation.
  • Expérience des méthodologies de validation de système informatisé, 21 CFR Part 11, et des règlements d’intégrité des données.
  • Connaissance approfondie et compréhension des processus de validation des systèmes informatiques et des exigences réglementaires, y compris les directives de la FDA et les cGMP relatives aux exigences à la norme 21 CFR Part 11 et aux directives ISPE / GAMP 5
  • Connaissance approfondie des directives de la FDA et des cGMP internationaux en rapport avec les exigences de conformité à la norme 21 CFR Part 11, la validation des systèmes informatiques et les directives ISPE/GAMP.
  • Connaissance des directives de l’industrie, des réglementations américaines et internationales (FDA, ICH, ISO, EU) pour les environnements réglementés BPF.
  • Expérience dans l’un des domaines suivants: validation / assurance qualité de systèmes informatiques dans des environnements réglementés par la FDA (GxP); des outils de test automatisés, validation et qualifiation de divers systèmes informatiques utilisés dans des environnements de fabrication; développement de documentation de validation complète et des protocoles de test (QI / QO / PQ).
  • Capable de développer et d’écrire la documentation de validation applicable, y compris, mais sans s’y limiter, URS, DOE, FAT, IQ, OQ
  • Expérience en gestion de projet serait un atout

Habilité, connaisance et aptitudes

  • Bilingue : français et anglais parlé et écrit (requis)
  • Capable de gérer plusieurs projets complexes et de travailler de manière indépendante
  • Capacité à examiner et à approuver efficacement les rapports techniques
  • Capacité à rédiger des rapports techniques de manière claire et précise
  • Peut travailler sous pression et s’adapter aux changements
  • Bon sens des communications et des urgences (hiérarchisation des priorités)
  • Travail en équipe multifonctionnel
  • Maîtrise des outils informatiques tels que Microsoft Office, Outlook, MS Project.
  • Travail de bureau et en usine
  • Des déplacements vers les sites de production peuvent être requis

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Buyer

Overview

Reporting to the Director of Production, the Buyer leads sourcing and purchasing as well as inventory planning and procurement activities. The Buyer provides inventory management and distribution support to maintain production operations and customer product availability while ensuring financial performance and optimized service. This includes managing vendor performance, mitigating supply issues, planning and effectively managing stock and replenishment activities. He/ she will be responsible for the following:

Sourcing/purchasing

  • Source, purchase, and negotiate prices for raw materials, consumables, packaging components, and other miscellaneous items to meet current and new client demands, all while ensuring suppliers meet quality expectations and on-time delivery while optimizing the total cost;
  • Provide prompt and accurate pricing and delivery lead time quotations;
  • Use industry resources to locate sources for products and services whether locally or international;
  • Issue Purchase Orders to vendors;
  • Support and participate in the negotiation of prices and terms with suppliers;
  • Perform follow-up activities on purchase orders and shipment tracking information to ensure on-time deliveries;
  • Coordinate and work closely with other Departments (such as Quality Assurance, Research & Development, Sales, etc..) to meet material specifications;

Replenishment and inventory management

  • Support and participate in the preparation and communication of procurement plans or forecasts to suppliers;
  • Perform required replenishment orders based on forecasts established with Demand Planning.
  • Trigger issues and adjust all key orders based on forecasts with optimal impact on balanced KPIs for Service Level, Inventory Levels, and revenue generation;
  • Identifies operational and strategic issues and proactively drives solutions;
  • Plans, foresees and communicates upcoming risks and inventory issues via pro-active management by comparing projected inventory levels with demand forecasts;

Production & Demand Planning:

  • Production and Demand Planning for forecast development internally and externally (suppliers and customers) to meet both short-term and long-term planning needs;
  • Work in partnership with Operations for inventory procurement impacts on the physical network and inventory/space optimization;
  • Manage overstocks, out-of-stocks, aged inventory, non-compliance and operational issues, by comparing real and projected inventory to physical and labor capacities;
  • Maintain and update Open Order Reports and Production Planning Reports;

Education and/or Experience

  • Bachelor’s Degree in Business Administration, Operations Management, or equivalent;
  • Minimum 5 years of experience in buying, planning, inventory management and procurement;
  • Pharmaceutical experience, a must.
  • Previous soft gel operations experience an asset;
  • Familiar with GMP environment;
  • Bilingual French/English – Spoken and Written
  • Extensive knowledge of MS Office products (Power Point, Excel, Word, Project;
  • Knowledge of process and project management;
  • Ability to work as part of multi-functional teams and ability to collaborate with various levels of management and employees;
  • Strong business acumen;
  • Demonstrated leadership abilities;
  • Excellent partnering skills and ability to build strong relationships;
  • Excellent communication and negotiation skills.
  • Strong analytical skills.

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Packaging Operator – Night Shift

Overview

Capcium is looking for a Packaging Operator to join its growing and dynamic team. The operator will be responsible for inspecting, polishing, and packaging Finished Product in accordance to work instructions and Standard Operating Procedures (SOP’s) in a Good Manufacturing Practices (GMP) environment.

The work schedule is either a 10-hour shift, 7 pm to 5:30 am, Monday to Thursday OR a 12-hour shift, 7 pm to 7 pm, Monday to Wednesday.

We offer two 20 minute paid breaks, one half-hour unpaid meal break, as well as full group insurance after 3 months. A pair of steel-toed boots will also be paid for after 3 months.

Main Responsibilities

  • Inspect capsules for defects
  • Test capsules to determine if drying is complete.
  • Polish capsules.
  • Package products in bulk containers.
  • Clean and sanitize equipment according to procedures;
  • Accurate and legible documentation of usage and cleaning logs and production parameters per the Batch Record;
  • Performs all duties in compliance with safety rules, work instructions, and SOP’s;
  • Perform other duties as assigned.

Qualifications

  • High school diploma or equivalent
  • College certification from a biopharmaceutical technology program is considered a strong asset
  • Manufacturing experience in a GMP environment (an asset)
  • Basic math skills
  • Functional bilingualism (French and English)
  • Must not be color-blind
  • Must be able to lift 30 pounds
  • Ability to stand for 10 hours
  • Ability to handle empty pallets
  • Ability to handle full pallets of finished product on a pallet jack
  • Strong work ethic
  • Advanced attention to detail
  • Fast learner
  • Able to complete repetitive work
  • Occasional exposure to strong odors
  • Proper personal hygiene
  • No facial piercings, no loose jewelry

This is a full-time, permanent position

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