Facility Technician Co Op - Toronto, Canada - Centre for Commercialization of Regenerative Medicine

Centre for Commercialization of Regenerative Medicine

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

About CCRM:

Role Summary:

As Facility Technician (CO-OP) (CCVP) within the Centre for Cell and Vector Production (CCVP), you are an individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine.

You will support CCVP's manufacturing services, including fee-for-service work, contract manufacturing, and access services, by providing technical assistance to the CCVP Facility Coordinator and the broader Operations team, assisting in maintaining the GMP facility and equipment as well as supporting ongoing manufacturing projects.

Responsibilities:

Support daily operational activities related to the GMP manufacturing of cell and gene therapy products by assuring the availability of equipment, setup and operation of all production equipment.
Provide direct support to assure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation.
Responsible for performing daily checks in the GMP facility. These include equipment verification, utility system verification and inventory checks.
Support the CCVP facility coordinator with onsite contractor and vendor management. Escort personnel into Grade C and Controlled and nonClassified spaces for maintenance, cleaning and other facility related activities.
Perform and/or assist with facility and equipment preventative and corrective maintenance activities.
Assist with monitoring and management of the Facility Monitoring Systems (FMS) and Building Automation System (BAS).
Responsible for reporting deviations observed in the facility to the CCVP Facility Coordinator and Quality Assurance.
Assist with facility, equipment and environmentalrelated deviation investigations.
Maintain facility logs.
Provide technical support for documentation related to equipment operation and maintenance.
Assist the manufacturing/operations associates with activities including but not limited to transfer of equipment and all incoming materials into the production suites (Grade B clean rooms), control rate freezing and storage of cell and gene therapy products.
Understanding and being knowledgeable in all facility standard operating procedures (SOPs).
Support line clearance and cleaning verification activities as per SOPs and meet changeover targets to support productivity goals.
Replenish gowning materials for the facility users.
Perform cleaning, decontamination and assemble manufacturing equipment according to our SOPs.
Become familiar with all facility equipment, so that you may assist clean room operations personnel, when required.
Ensure required documentation is prepared ahead of time so that the thirdparty cleaners and contractors can work efficiently.
Perform documentation review, ensuring Good Documentation Practices (GDP) are followed.
Perform facilityrelated administrative tasks, such as document scanning and responding to document requests from the broader team.
Support the Supply Chain team with accepting deliveries and transporting deliveries to the receiving area.
Provide Grade C assistance to the clean room personnel during batch production activities.
Perform any related duties, as assigned.

Requirements:

23 years in a Bachelor's program or Diploma program in a Life sciences/Engineeringrelated discipline (chemical engineering, mechanical engineering, etc.).
1+ years of experience in cell therapy/viral production, or similar, within the pharmaceutical, medical technologies, biologics or similar industries.
Strong understanding of facility and process equipment.
Strong English written and oral communication skills.
Requires a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and/or responding to callin emergency situations.

Desired Characteristics:

Takes a collaborative approach to working with crossfunctional teams, with good multicultural awareness.
Demonstrated initiative and the ability to deliver highquality outcomes.
Leads by example by proactively identifying problems and areas for improvement.
Excellent communication skills.
Ability to read and understand technical documents.
Diligent and service minded.
Excellent organizational skills with an eye for detail.
Ability to take direction.
Enthusiastic and willing to learn.

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

CCRM is committed to accessibility, diversity, and equal opportunity.

Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position.

Applicant