Project Engineer - Validation
The Project Engineer will be directly involved in the validation of new equipment, providing support on process introduction and or process changes.
- Drafting of documentation and Execute validations on new equipment introductions/processes/process changes. Examples include URS development/IQ/OQ/PQ+PV/Validation Plans/Risk Assessments/pFMEA/ Test Methods
- Work in a manufacturing environment adhering to appropriate quality standards, work instructions and Health & Safety considerations.
- Acts as a liaison to external suppliers regarding contracted products, tools & fixtures and their manufacture, acting as a technical expert or complete special projects in individual areas of expertise (i.e. programming, tooling, packaging, finishing etc.
- Work in cross-functional project teams in order to accomplish new product implementation, process design, process improvement or any other technical manufacturing issues.
- Drive process improvements/capacity increases through new technology/equipment introductions.
- Prepare and maintain of relevant system specifications.
- Identify and lead cost and technical improvements under the customer’s continuous improvement programs.
- Provide timely and accurate reporting on project activities
- Degree qualified in a relevant Engineering / Science discipline, with relevant experience in at least 2 Major Projects would be preferable
- Experience in regulated industry, FDA, ISO, etc for Medical Devices/Pharma
- Experience in project management utilizing organizational skills
- Ability to lead significant projects to completion, on time and managing budget.
- Leadership skills and the ability to make effective decisions.
- Knowledge of Clean lines and Non-Destructive Testing Methods would be advantageous
Other Information/Additional Preferences:
- Knowledge of cleaning systems and In-process clean systems, pre and post clean inspection processes and execution of activities.
- Knowledge of cleaning technologies, ultrasonic cleaning, immersion cleaning, blast cleaning.
- Understanding of water purification generation systems.
- Understanding of Validation and Computer Systems Validation.
- Demonstrated qualification and background within a regulated industry.
- Experience of equipment procurement, cost management and schedule development.
- Demonstrated level of problem solving and facilitation skills.
- Working and collaboration across multiple functional teams.
For a confidential discussion and more information on the role, please contact Josh Barnes.