Description
I have an immediate opening for a Validation Engineer with a world leading medical device company based in Cork. This is a fixed term contract position that will run until the end of 2016.This company offers an excellent salary/benefits, fantastic opportunities for career development as well as an excellent work life balance.
Reporting to the Quality Manager, you will participate in and coordinate Process Validations and Risk Management Studies. On a daily basis you will be required to demonstrate your engineering expertise, your excellent interpersonal skills, your strength in problem solving and your fit within an environment where ownership of results and adherence to standards and procedures is routine.
Key responsibilities include:
- Develop and execute facility, process and equipment validations with regulatory, corporate requirements and business requirements.
- Manage validation remediation project on site and provide regular updates to management.
- Perform process improvement studies, complete process validations and Risk Management to improve quality rates and cycle times for our product line.
- Conduct a review for compliance to Quality System requirements and project documentation including validation and software documents.
- Statistical analysis to assist with validation developments and process improvements.
- Maintain/Support the Risk Management and Validation System in compliance with International requirements.
- Adhere to in-house H&S and environmental requirements.
- Ensure continual Quality System compliance by adherence to established and evolving QS requirements
Candidates should have:
- Honours Bachelor's degree a technical discipline.
- 4-6 years' technical experience in the medical device, pharmaceutical or soft contact lens industry including validation and leadership experience.
- Further qualifications such as a Masters in Technical/Physical Sciences/Statistics for reduced experience will be considered.
- Knowledge of FDA, medical device, GMP and validation requirements.
- Experience in equipment and process validations.
- Project management, problem solving, statistical analysis are key areas of expertise for this role.
If you are interested in hearing more about these excellent opportunities please apply directly to this advert or contact Derek Sheridan for immediate consideration.