JOB SUMMARY :
Prollenium is a Canadian-based company focused exclusively on the research and manufacturing of medical devices. Our commitment to product development, innovative research and manufacturing means we will continue to revolutionize the medical aesthetics market while maintaining to be one of the leading manufacturers of HA fillers, worldwide. Prollenium provides competitive compensation, benefits and development opportunities.
The Process Technician is responsible for supporting manufacturing and general operations at Prollenium Medical Technologies Inc. and reports to the Manufacturing Supervisor.
MAJOR RESPONSIBILITIES :
- Adhere to GMP and ISO13485 quality systems
- Perform line clearance and manufacturing clean-up operations in Clean Room
- Participate in the Installation, operation and qualification of manufacturing equipment including filling lines, mixing and sterilization of equipment
- Participate in process validation activities, problem solving, quality improvement drives and process improvement projects
- Perform production process operation such as, but not limited to, formulation, milling, dialyzing, degassing, filling , sterilizing of manufacturing products as per master batch instructions
- Perform equipment calibration, corrective and preventive maintenance, documentation and maintenance of files
- Writing SOPs and manufacturing documentation
- Inventory management including ordering; stock control; order tracking and labeling
- Communicating with suppliers for material concerns and machine issues and perform troubleshooting when necessary
- Co-ordination of manufacturing set-up project with other departments including QC, QA and R&D
ADDITIONAL RESPONSIBILITIES :
Other duties as assignedParticipation in weekly operations meetingsMINIMUM QUALIFICATIONS :
Technical Knowledge / Experience
Three-year college diploma in a scientific field and 1-year work experience in a GMP / GLP orISO compliant environment in either Manufacturing, QC, QA, R&D or other technical functionExcellent written and oral communication skills.Experience working in Clean Room environmentBehavioural
Demonstrated ability to apply the following behavioral competencies on the job :
Teamwork : Working effectively and productively with othersWritten Communication : Writing clearly, succinctly and understandablyOrganization and Planning : Utilizing logical, systematic and orderly procedures to meetobjectivesFlexibility : Agility to adapt to changeWORKING CONDITIONS :
Requirement to work in clean room areas and laboratory setting up to 90% of the timePREFERRED QUALIFICATIONS :
Experience with IQ / OQ / PQ of manufacturing and / or laboratory equipmentExperience with calibration systems set up and performing equipment calibrationsInventory management systems : Set up and / or managementSOP writing experience