288 Chemical Process Engineer

Kardium has a unique opportunity for an experienced Chemical Process Engineer. As a member of the engineering team, the Chemical Process 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 Process Engineer will be responsible for:

Chemical Process 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 Process 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 “288 Chemical Process Engineer” in the subject line.

To apply for this job email your details to jobs@kardium.com