Reference Number:R2862709 Position Title: cP89 Media Technologist
Duration: Fixed Term Contract - 24 months
Location: Toronto, ON
Main Responsibilities: Administration of Media, Washing and Sterilization activities - Assist on review of Records, SOP, logbooks, and monitoring charts for completion and insurance of accuracy of all documents as per GMP guidelines.
- Train and ensure technical staff comply to cGMP, HSE, and SOP requirements
- Participate in daily meetings and report findings to management
- Participate in deviation investigations
- Coordinate with units within department (Upstream and Downstream)
Health, Safety, Environment- Wear proper PPE when performing tasks.
- Drive culture of HSE in department.
- Escalate any potential hazards in a timely manner. Help develop proposed solutions.
- Participate in routine HSE checks and inspections.
- Follow safety procedures.
- Ensure chemicals are stored as per HSE requirement, and has MSDS available.
Preparation of media, washing and sterilization, analytical testing, area monitoring, maintenance- Perform accurate formulation calculation and measurements of weigh and volume and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
- Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
- Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
- Provide guidance to technical staff on problem solving and trouble shooting.
- Ensure area is inspection ready. Knowledgeable to guide inspectors.
Administration of Data Information for GP Production - Complete SAP transactions on a timely, accurate manner.
- Perform Pharm net web activities.
- Enter all data accurately and in timely manner such as Shop Floor Data, LIMs, Master, change request forms.
Process improvement and development- Assist implementation of facility, equipment, and process improvement projects
- Assist in writing specifications, protocols and reports related to facility, equipment, and process improvement of production process
- Modification of SOPs and BPRs for new processes in accordance with change control policies
- Perform IQ, OQ, and PQ for new equipment
- Attend meetings with other support functions representing production as needed
Preparation of Trending reports and SPC data analysis - Assist with implementation of corrective actions in production
- Assist in CCR, CAPA as needed and manage them to completion as per committed due dates
Housekeeping- Participate in keeping the production area in a tidy, GMP manner, following 5S guideline (sort, straighten, shine, standardize, sustain)
- Disinfect area as required in SOP.
- Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
- Assist to ensure office area is kept in a tidy clean manner.
- Supply airlock with gowning materials
- Animate visual management tools
Minimum Qualifications: - Minimum four (4) years Bachelor's degree (Biochemistry, Microbiology, Bioengineering), plus a minimum of four (4) years of previous relevant work experience.
- Preferred two (2) years Master's degree (Biochemistry, Microbiology, Bioengineering), plus a minimum of three (3) years of previous relevant work experience.
Knowledge / Skills: - Sound Knowledge in Microbiology and Protein Purification
- Knowledge in Aseptic techniques, cGMP, cGLP
- Chemistry, Mathematics and basic mechanical skills and knowledge
- Computer skills, SAP, Visio, Autocad, MS Access, JMP
Hours Of Work: - Inclusive from Monday to Friday 6:00am to 2:00pm
This is subject to change at any time and it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation. Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position.
Pay transparency - $48.02 per hour 
