Contact us

Have questions? Want to talk about your next project? Our experts are here to help. Please complete the form below and we will be happy to respond to you.

Cancel

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.

Executive Assistant

Overview

The Executive Assistant`s main goal is to provide administrative support and coordination to the Executive & Management Team on daily tasks, travel, meetings, and other administrative duties.

Main Responsibilities

  • Administration
    • Answer calls & take messages
    • Schedule meetings & coordinate calendars
    • Ensure agendas are provided for meetings
    • Arrange refreshments
    • Take meeting minutes
    • Type letters memos & other documents
    • Translate documents
    • Act as gatekeeper for solicitors & sales representatives

 

  • Travel
    • Research & book flights based on budget and other criteria
    • Make hotel reservations
    • Coordinate off-site meetings
    • Arrange meals, snacks & refreshments
    • Research & propose off-hours activities
    • Complete & submit expense reports with necessary receipts
    • Reschedule travel as needed while minimizing costs

 

  • Event Coordination
    • Source out possible event locations
    • Manage guest list and send invitations
    • Arrange logistics, catering, documented materials
    • Coordinate rental of various equipment such as projectors, screens, speakers and whiteboards
    • Gather feedback after events for future bookings and reference
    • Oversee event budget and ensure cost containment
    • Deal with unexpected changes, apply plan B
    • Address complaints with vendors and manage the reconciliation process

Requirements

  • Minimum five (5) years’ experience in administration and/or as an Executive Assistant
  • High School diploma (Diploma in Office Administration is an asset)
  • Excellent communication skills required; fluent English & French (oral & written)
  • Excellent time management, planning, and organizational skills
  • Ability to maintain a professional and positive image
  • Advanced knowledge of Microsoft Office (Word, Outlook, Excel, and PowerPoint)
  • Strong writing skills, able to be clear, concise and professional

Apply for this job

Validation Specialist

Overview

As a Validation Specialist, you will be responsible for carrying out validation activities for equipment, systems, utilities, IT, process and cleaning at Capcium. You will need to ensure that all stages of the project are conducted in accordance with standard procedures (Health and Safety, Good Manufacturing Practices, etc.). You will coordinate the activities of all parties involved: professionals, contractors, consultants, and serve as a link to internal customers. You will also review and approve documents (protocols and reports).

The Validation Specialist will be reporting to the Validation Manager.

Main Responsibilities

  • Drafting and approval of validation protocols and reports (IQ, OQ, and PQ when relevant)
  • Planning and execution of qualification/validation protocols within the expected timelines
  • Qualification of production equipment and Laboratory instruments (autoclave)
  • Qualification of systems, utilities and IT (network and software)
  • Process Validation, and cleaning validation
  • 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

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)
  • 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

Machine Assembler - Night Shift

Overview

The Machine Assembler is responsible for the disassembling of high tech, fully automated encapsulation machines, performing required maintenance/sanitizing and reassembling all machine parts and components.  Work must be performed according to the work instructions and Standard Operating Procedures (SOPs). The work schedule is a 10-hour shift, Tuesday to Friday, from 7 pm to 5 am.

Main Responsibilities

  • Carefully remove all parts & components of encapsulation machine
  • Place parts in proper places to ensure ease of reassembly
  • Perform routine sanitizing of various parts of the production equipment
  • Reassemble all machine parts, from large drums to small bolts
  • Dispose of garbage in appropriate receptacles
  • Clean production rooms and sanitation room
  • Safely working with a variety of chemicals
  • Notifying management of equipment that is not working properly
  • Perform other duties as assigned by supervisor or other lead operator

Qualifications

  • High school diploma or equivalent
  • Must be 18 years of age or older
  • Have good mechanical aptitude and willingness to learn
  • Manufacturing experience in a GMP environment (an asset)
  • Have the physical ability to do the required work
  • Ability to stand for 10 hours
  • Strong work ethic
  • Ability to work autonomously, responsibly and conscientiously
  • Have the ability to comprehend basic verbal instructions, read product labels & safety warnings and perform work according to SOP
  • Be reliable and dependable
  • Available to work night shift Tuesday to Friday and occasionally Saturday or Sunday as directed by management
  • Have a high level of job motivation and ability to work with minimal supervision

Physical Requirements

  • Reach, stoop and bend at waist repetitively throughout the entire shift
  • Lift and move up to 50 pounds of equipment pieces
  • Push/pull wheeled cart weighing 80 to 100 pounds
  • Ability to walk and/or stand for the entire shift

Apply for this job

 

 

Packaging Operator - Night Shift

Overview

The Packaging Operator is responsible for inspecting, polishing, and packaging Finished Product in accordance with work instructions and Standard Operating Procedures (SOP’s) in a Good Manufacturing Practices (GMP) environment. The work schedule is a 10-hour shift, 7 pm to 5 am, Monday to Thursday..

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;
  • Perform all duties in compliance with safety rules, work instructions, and SOP’s;
  • Perform other duties as assigned.

Qualifications

  • High school diploma or equivalent;
  • Manufacturing experience in a GMP environment (an asset)
  • Basic math skills;
  • Functional bilingualism (French and English);
  • Must not be color-blind
  • 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

Apply for this job

Associate Scientist

Overview

Reporting to the Head of Product Development, the Associate Scientist will execute assigned tasks associated with new product development and assessment with quality, speed, and efficiency for multiple projects in the portfolio. The Associate Scientist will gain familiarity with various aspects of the drug development process in a regulated environment, including topics such as Quality by Design (QbD), Design of Experiment (DOE), and compliance with regulatory guidelines.  The Associate Scientist will work under the direction and supervision of the department head.

Essential Duties and Responsibilities

  • Execute against assigned formulation lab activities with quality, speed, and efficiency to ensure on-time delivery
  • Execute individual tasks related to formulation development, excipient compatibility assessment, data analysis, and good documentation practices
  • Assist in aspects of complex formulation design and development
  • Assist in the development of formulation assessment technique.
  • Communication of project assignment status and timely escalation of issues
  • Presentation of project information at local reviews
  • Maintain compliance with training, best practices, safety, and cleaning requirements
  • Operate under and maintain GMP/GLP conditions
  • Support Capcium strategies, initiatives, expectations, processes and portfolio commitments
  • Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
  • Perform other duties as required

Supervisory Responsibilities

  • Indirectly supervises area activities during tech transfer or process validation
  • Ensures that employee-related tasks are completed timely including time/attendance, performance reviews, corrective action, and training.

Education and/or Experience

  • Masters or Bachelor’s Degree in Life Sciences (Chemistry, Biochemistry) or related field.
  • Three (3) years of related experience with pharmaceutical, manufacturing and/or GMP facilities.
  • Ability to thrive in a high-performance culture
  • Strong computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word), MS Project.
  • Advanced research and writing skills

Apply for this job

Formulation Operator

Overview

The Formulation Operator is responsible for preparing batches of fill material, gel mass, and other mixes in accordance to work instructions and Standard Operating Procedures (SOP’s) in a Good Manufacturing Practices (GMP) environment. The work schedule is an 8 hours shift, 5 days per week, either a day shift (7 am to 3 pm), an afternoon shift (3 pm to 11 pm) or a night shift (11 pm to 7 am).

Organizational Structure

The Formulation Operator reports to the shift Production supervisor.

Main Responsibilities

  • Weigh and subdivide bulk materials in accordance with manufacturing procedures for gel masses, fill materials, other mixes;
  • Load material into designated equipment according to Batch Record instructions and ensure proper mixing of raw materials,
  • Operate a range of equipment including and not limited to: melter, Ystral mixer, lab mixer, tabletop balances, floor scales, pallet jack, walk-behind power lift, net grinder, drum heater, drum lifter
  • Ensure equipment and working area meets all required sanitary standards and procedures;
  • Use small hand tools to disassemble pumps, receivers, mixers, and other equipment,
  • Clean and sanitize equipment according to set procedures and reassemble prior to mixing a new batch product;
  • Accurate and legible documentation of usage and cleaning logs and production parameters per the Batch Record;
  • Document the inventory of raw materials and departmental supplies;
  • Performs all duties in compliance with safety rules, work instructions, and SOP’s;
  • Perform other duties as assigned.

Qualifications

The ideal candidate must have the following qualifications:

  • High school diploma or equivalent;
  • Manufacturing experience in a GMP environment (an asset)
  • Basic computer skills (including Excel, outlook and data entry) and math skills;
  • Functional bilingualism (French and English);
  • Ability to stand for 8 hours;
  • Ability to handle 200kg drums on pallets
  • Ability to handle 30kg packages such as gelatin bags, boxes of wax, etc.
  • Strong work ethic.

Apply for this job

Maintenance Manager

Overview

The building maintenance manager oversees the maintenance of buildings and mechanical systems within these buildings. It controls the installation, repair, and maintenance of the property. The building maintenance manager oversees the repair of items such as kettles, HVAC system, heating, and air conditioning.

Organizational Structure

The position of Building Maintenance Manager reports to the Senior Project Manager.

Main Responsibilities

  • Development of equipment maintenance procedures and ensuring implementation
  • Development of a preventive and predictive maintenance system of equipment
  • Develop and implement a plan to calibrate critical instruments
  • Plan and supervise all repair activities
  • Spread workload and supervise building maintenance personnel (technicians, guards, janitors, etc.)
  • Check hardware inventory and place orders when necessary
  • Monitor spending and control maintenance budget
  • Manage relationships with contractors and service providers
  • Keep maintenance logs and report on day-to-day activities
  • Ensuring compliance with health and safety policies
  • Coordinating the implementation of utilities with contractors (BTL)
  • Support validation activities for building equipment and utilities
  • Controls and manages the BAS system and attached equipment
  • Participation/audit support: clients, Health Canada, ISO…

Qualifications and Experience

  • Technical mechanical training of buildings and equipment, or equivalent experience
  • Minimum five (5) years of experience in a related position
  • Pharmaceutical environment experience is considered a strong asset
  • Mastery of GMAO system
  • Advanced computer skills, including Excel

Apply for this job

 

Validation Manager

Overview

As Manager Validation, you will be responsible for planning validation activities for equipment, systems, utilities, IT, process and cleaning at Capcium. You will need to ensure that all stages of the project are conducted in accordance with standard procedures (Health and Safety, Good Manufacturing Practices, etc.). The Manager Validation is responsible for ensuring that the development and implementation of validation plans and protocols are adhered to and that they are continually updated. You will coordinate the activities of all parties involved: professionals, contractors, consultants, regulatory agencies, and serve as a link to internal customers. You will also review and approve documents (protocols and reports) from Validation Specialists.

Organizational Structure

The Validation Manager will be reporting to the Vice-President Compliance & Regulatory Affairs.

Main Responsibilities

  • Provide expertise in the development, execution, and revision of validation protocols.
  • Develop and maintain a requalification schedule for facilities, equipment and process based on a risk assessment, current industry “best practices” and regulatory requirements.
  • Able to plan staff to meet aggressive validation deadlines.
  • Responsible for updating, compliance, and implementation of master plan validation schedules.
  • Coordinate and interact with operations, quality, and engineering groups. Lead multifunctional teams, including external resources, to ensure the successful execution of projects.
  • Review and approve validation protocols – installation, operation and performance qualification of manufacturing and packaging equipment, utilities, systems, computer, process, and cleaning.
  • Supervise the execution of protocols
  • Establish a system for managing documentation related to validation activities
  • Participate in the resolution of gaps, investigations, and deficiencies
  • Participate in assessments and updates of change controls for validated systems
  • Participate in regulatory audits as an expert in validation
  • Participate in periodic meetings of the validation team
  • Provide leadership and coaching and staff performance; identify training needs and staff development, if applicable
  • Develop and maintain a departmental operational plan (capacity planning and planning), monitor performance (productivity reports), analyze gaps and propose solutions
  • Lead and support operational excellence initiatives to support the objectives of the site.

Qualifications and Experience

  • Bachelor’s degree in Engineering (Chemistry or Mechanics) or Science: Chemistry, Biology, Biochemistry
  • Minimum of 5 years of experience in validation in the pharmaceutical industry
  • Minimum of 2 years of experience in supervision
  • 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)
  • 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 hiring, guiding and training staff and other resources as needed.
  • 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 team work
  • 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

Director Logistics

Overview

The Director Logistics is responsible for managing all activities at our warehouse including receiving, warehousing, shipping and delivery of raw materials, components and product in a manner consistent with company service and cost objectives. The Director Logistics is empowered to make decisions that lead to accurate inventory data, streamlined receiving/picking/shipping processes and a well-organized, efficient, clean and safe environment. The incumbent will also assume leadership for the planning and buying of all material.

This is a hands-on position in a small company environment. The person fulfilling this role will require strong knowledge of all company information and technology systems as well as the ability to lead a team to develop and support these systems.

Organizational Structure

The Director Logistics will be reporting to the Vice-President Operations.

Main Responsibilities

  • Oversee daily activities in the designated areas of shipping, receiving, and warehousing work centers at both in-house and offsite locations
  • Develop and maintain warehouse operational standards by contributing warehouse information to strategic plans and reviews; implementing production, productivity, quality, and customer-service standards; resolving problems; identifying warehouse system improvements
  • Develop and maintain strict control over inventory levels in order to meet internal and external demand of product
  • Identify discrepancies between inventory records and take action
  • Ensure proper storage of all materials in warehouse as per GMP requirements as well as handling & storing of rejected materials/solid waste at the designated areas
  • Develop and maintain tools for performing the detailed production planning and purchasing functions; accountable for all supply management activities.
  • Supervise, coach, train and mentor team members; create, maintain and improve a safe and efficient environment for the warehouse team and ensure team members are trained to operate in an efficient and safe manner
  • Works with cross functional teams including Project Management, R&D, Quality, Manufacturing, and our customers to develop and implement robust Supply Chain Management Plans
  • Partner with the Director Production and Site Leadership Team to ensure production and cost targets are met

Qualifications and Experience

  • BA/BS Degree; or Equivalent
  • Minimum of 3 -5 years’ experience in Warehouse management with supervisory experience in pharmaceutical industry
  • Proficient in Warehouse Management Systems (WMS) and Management Resource Planning (MRP)
  • Expertise in warehouse management procedures and best practices
  • Supervisory or management experience preferred

Knowledge and Abilities

  • Ability to work independently and meet deadlines
  • Must be able to multi-task and follow-up when responses are needed
  • Knowledge of cGMPs, SOPs, and GDP’s
  • Proven ability to work in a fast-paced, entrepreneurial environment
  • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
  • Functional knowledge of French and English language, both written and verbal, is required.

Apply for this job