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.
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)
- 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.
- Excellent interpersonal skills.
- Flexible and able to take on additional responsibilities as appropriate.
How to Apply
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