Process Technician

Prollenium Medical Technologies Inc.; Aurora; On-site; CAD 55,000 - 76,000; Full time

Job summary

Prollenium Medical Technologies Inc. in Aurora, Canada, is seeking an Aseptic Process Technician to join the manufacturing team in an ISO5 Cleanroom.

The role involves material preparation, line clearance, formulation, aseptic filling, and final sterilization, with emphasis on equipment setup and routine troubleshooting. You will ensure GMP/ISO13485 compliance, participate in equipment qualification, changeovers, process validation, and documentation, plus inventory management and

Qualifications

• Three-year college diploma in a scientific field (or equivalent).
• Experience in GMP/GLP or ISO compliant environment in Manufacturing, QC, QA, R&D or other technical function.

Responsibilities

• Adhere to GMP and ISO13485 quality systems.
• Perform line clearance and manufacturing clean-up in Clean Room.
• Participate in installation, operation and qualification of manufacturing equipment.
• Participate in process validation, problem solving and quality improvement projects.
• Perform production processes including formulation, milling, degassing, filling and sterilization as per master batch instructions.
• Equipment calibration and preventive maintenance; maintain documentation.
• Write SOPs and manufacturing records.
• Inventory management and stock control; order tracking and labeling.
• Coordinate manufacturing setup with QC, QA and R&D; communicate with suppliers for material concerns.

Skills

GMP/GLP experience

ISO compliant environment

Clean Room operations

Documentation

Education

Three-year college diploma in a scientific field

Tools

IQ/OQ/PQ qualification experience

Calibration systems setup

Job description

Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of new and exciting products that provide safe and effective results. With regulatory approvals from the US FDA and Health Canada, Prollenium has sold over 5 million syringes from its Revanesse® product line across more than 80+ countries worldwide. Prollenium was the first manufacturer of hyaluronic acid dermal fillers in North America. Join our dedication to innovation. Prollenium provides competitive compensation, benefits, and development opportunities.

JOB SUMMARY:

An Aseptic Process Technician is a member of the manufacturing team who will be working in an

ISO5 Cleanroom environment. The Technician performs and monitors production activities, such

as material preparation, line clearance, formulation, aseptic filling, and final sterilization. The

Technician is expected to be well versed in equipment set up and operation. The Technician is also

capable of conducting primary troubleshooting on routine operations.

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

Note: Please note this is a 12-months contract role.

Shift Timings:

2pm - 10pm (Monday to Friday)

The position is based in Aurora.

Note: We use AI-enabled tools to support certain aspects of our recruitment process.