333 Chemical Processing Engineer

Kardium has a unique opportunity for an experienced Chemical Processing Engineer. As a member of the engineering team, the Chemical Processing Engineer will be responsible for the development, transfer, start-up, and improvement of all chemistry-related manufacturing processes at Kardium’s Burnaby production facility.

Responsibilities

The Chemical Processing Engineer will be responsible for:

Chemical Processing Development:

• Develop robust, scalable, validated chemical processes for combination products.
• Characterize processes; construct and execute controlled experiment (including DOEs) and interpret results to evaluate critical process parameters and material attributes.
• Recommend raw material requirements and work with the Purchasing department on vendor selection and qualification.
• Author protocols, pharmaceutical development reports, SOPs and other technical documents, which may support regulatory filings.
• Transfer processes, knowledge and technologies into production.

Chemical Processing Engineering:

• Determine manufacturing suites requirements such as layout, flows, classifications, and utilities requirements.
• Assess process equipment requirements to meet demand and quality objectives.
• Design, install, commission, and qualify new production equipment.
• Write equipment specifications and qualification protocols and reports.
• At clinical and commercial manufacturing scale, assess process variability, stability and capability, and suggest and implement process improvements and control strategies.
• Identify opportunities to maximize throughput, minimize waste and improve safety while maintaining the highest standard of quality.
• Develop Standard Test Methods (STMs) for incoming chemical material and chemical process output testing, and plan, execute and document STM validation as required.
• Coordinates testing at external laboratories, as needed.
• Write Standard Operating Procedures (SOPs) and Work Instructions (WIs), and train operators and lab analysts in the new processes and STMs.
• Ensure new production processes and STMs are compliant with Kardium’s medical device quality management system (QMS)

Manufacturing Engineering:

• Provide technical support to daily operations of chemical processes.
• Troubleshoot processes, identify non-conformance root causes and assist in the implementation of preventive and corrective actions.
• Develop strategies for process improvements to support manufacturing objectives for cost, quality, safety, and on-time delivery.
• Participate in Material Review Board (MRB) meetings when required, ensuring that non-conforming materials are dispositioned efficiently.

Experience and Qualifications

• Bachelor’s degree in chemical engineering.
• Minimum 5 years’ experience in plant operation and production engineering in a regulated manufacturing environment, preferably in the medical devices, diagnostics, or pharmaceutical industries.
• Practical knowledge of worldwide GMPs, regulatory requirements, and quality management systems for medical devices.
• Strong, practical knowledge of R&D, NPI, supply chain, quality control, and quality assurance.
• Strong experience with process value stream mapping and change control management.
• Experience with and solid understanding of statistical process controls, lean manufacturing, six-sigma implementation.
• Demonstrated ability to manage multiple projects with a high degree of accuracy and timeliness.
• Experience with combination medical device/pharmaceutical products.

Skills and Attributes

• Strong analytical skills and critical thinking.
• Excellent ability to troubleshoot and problem-solve, and to lead root cause analysis of quality issues in a manufacturing environment.
• Effective written and verbal communication and technical documentation skills.
• Able to operate independently with minimal direction.
• Detail-oriented.
• Excellent interpersonal skills.
• Flexible and able to take on additional responsibilities as appropriate.

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “333 Chemical Processing Engineer” in the subject line.