Process Technician
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 Manufacturing Associate 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 assigned
- Participation in weekly operations meetings
MINIMUM QUALIFICATIONS :
Technical Knowledge / Experience
- Three-year college diploma in a scientific field and 1-year work experience in a GMP / GLP or
- ISO compliant environment in either Manufacturing, QC, QA, R&D or other technical function
- Excellent written and oral communication skills.
- Experience working in Clean Room environment
Behavioural
Demonstrated ability to apply the following behavioral competencies on the job :
- Teamwork : Working effectively and productively with others
- Written Communication : Writing clearly, succinctly and understandably
- Organization and Planning : Utilizing logical, systematic and orderly procedures to meet
- objectives
- Flexibility : Agility to adapt to change
WORKING CONDITIONS :
Requirement to work in clean room areas and laboratory setting up to 90% of the time
PREFERRED QUALIFICATIONS :
- Experience with IQ / OQ / PQ of manufacturing and / or laboratory equipment
- Experience with calibration systems set up and performing equipment calibrations
- Inventory management systems : Set up and / or management
- SOP writing experience
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