GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below:
The Project Engineer will report into Division Engineering and will be involved in identifying and implementing process improvements on existing automation equipment and complete the validation activities associated with the installation of new equipment and updates to existing equipment. The incumbent will ensure that the assigned areas of validation are effectively managed, and all elements follow the requirements specified by the company Division Quality System and the relevant international standards.
Primary Job Function
- Development of the validation strategy for projects and gain agreement with stakeholders including Owner, Technical and Quality on approach.
- Identifies opportunities to improve equipment process capability, robustness, and efficiency. Detects and isolates sources of variation in processes. Utilizes Root Cause Analysis, Lean manufacturing, and Six Sigma tools in decision making.
- Orchestrates validation activities. Works with cross functional teams to validate automated processes. Completes risk analysis (through FMEA and other risk analysis tools) to identify process and equipment risk areas. Develops protocols for testing equipment. Executes test plans, and documents results in validation reports. Develops statistically sound sampling plans and incorporates statistical analysis on results to confidently reach data driven conclusions.
- Documenting and Managing Change – Justifies changes and executes these changes through the quality system to properly implement project outcomes.
- Collaborates across functional areas – Interprets; presents; and delivers information with senior team members; scientists; engineers; and other systems development personnel across sites. Works with cross functional team in collaborative environment.
- Complete all activities in a safe manner, ensuring that any potential safety issues and areas for improvement are addressed.
Accountability / Scope
- Receives general direction for process improvement and validation deliverables. Plans and implements validation activities for multiple projects / lines.
- Ensures project risks are addressed and appropriate technical skills are assigned.
- Bachelor’s degree in engineering or technical discipline, plus demonstrated competence.
- Two years progressive work experience in Engineering/Process Improvement role with validation experience
- Expertise in the validation of automated processes for medical devices
- Lean Six Sigma experience.
- Experience in project leadership
- Experience in troubleshooting and problem resolution
- Expertise in the development of assembly automation solutions, robotics, and complex machine controls preferred.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Project Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.