Facility Technician Co-op

7 months ago

Toronto, Canada CCRM Full time

**Department**:
Deliver

**Co/Op Term**:
12-16 Months

**About** **CCRM**:
CCRM, based in Toronto, Canada, is a unique not-for-profit group that is developing and commercializing cell and gene therapies and regenerative medicine technologies. We are leveraging our network of academics, industry partners and investors to tackle significant problems and advance our most promising technologies to the market to meet the needs of patients. For more information about CCRM, please visit our website at ccrm.ca.

**Role** **Summary**:
As Facility Technician (CCVP) of Deliver, a business unit of CCRM that operates the Centre for Cell and Vector Production (CCVP) facility, 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, access services, by providing technical assistance to the CCVP Facility Coordinator and broader Deliver Operations team, assisting in maintaining the GMP facility and equipment as well as supporting ongoing manufacturing projects.

**Responsibilities**:

- Supports daily operational activities related to the GMP manufacturing of cell and gene therapy products by assuring the availability of equipment, set-up, and operation of all production equipment.
- Provides 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 non-Classified 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.
- Assists with facility, equipment, and environmental related deviation investigations.
- Maintaining facility logs.
- Provides 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 cleanrooms), control rate freezing and storage of cell and gene therapy products.
- Support line clearance and cleaning verification activities as per standard operating procedures and meet changeover targets to support productivity goals.
- Understanding and being knowledgeable in all facility SOPs.
- Replenishing gowning materials for the facility users.
- To perform cleaning, decontamination and assemble manufacturing equipment according as per standard operating procedures.
- Becoming familiar with all facility equipment, so that you may assist cleanroom operations personnel, when required.
- Ensuring required documentation is prepared ahead of time so that the third-party cleaners and contractors can work efficiently.
- Performing documentation review, ensuring Good Documentation Practices (GDP) are followed.
- Performing facility related administrative tasks such as document scanning and responding to document requests from the broader Deliver team.
- Supporting the Supply Chain team with accepting deliveries and transporting deliveries to the receiving area.
- Providing Grade C assistance to the cleanroom personnel during batch production activities.
- Requires a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and / or respond to call-in emergency situations.
- To perform any related duties as assigned

**Requirements**:

- Bachelor’s degree or diploma in a life sciences or engineering discipline (bioengineering, chemical engineering, mechanical engineering, biotechnology, cell biology, microbiology, chemistry, 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.

**Desired** **Characteristics**:

- Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.
- Demonstrated initiative and the ability to deliver high quality outcomes.
- Leads by example by proactively identifying problems and areas for improvement.
- Personable with excellent communication skills.
- Ability to read and understand techni

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