Position: Validation Engineer (12 month Fixed Term contract)
Location: Model Farm Rd, Cork
Benefits: Excellent salary, pension, healthcare and yearly bonus.
My client are a medical device company based in Cork, a forefront company in their field. They are based in Cork City and have over 450 professionals here. They've been in Ireland over 25 years and their products touch the lives of more than 260 million patients yearly.
- Responsible for opening Change Controls
- Responsible for completion of all required GxP validation assessments.
- Responsible for preparing and gaining approval for the Project plan
- Responsible for preparing and gaining approval for the Validation Plan
- Responsible for coordination and completion of Risk Management documents and generation of all validation protocols.
- Execute pre-validation studies as required
- Equipment Validation and process validation protocol drafting
- Manage and execute the equipment and process validations
- Report to project manager on status of tasks.
- Coordinate all necessary associate training and release the necessary production SOPs and associated documentation.
- Generate all required validation reports
- Liaise with manufacturing to ensure successful go-live of equipment.
- Change Control Closure
Reporting to the Product Engineering Manager, this person is responsible for the planning, designing, coordinating, validating, and implementing of high technology equipment and/or processes for the production, finishing and inspection of IOLs and delivery system products. Provides engineering support to manufacturing to maintain high yields and minimize downtime of process equipment. Must also demonstrate analytical skills in problem solving.
- Demonstrated technical aptitude and competency. 2-5 years' experience in GMP manufacturing environment
- Preferred: 3-8 years' experience in medical device manufacturing. Experience with metrology systems. Experience with cross-site projects and R&D Liaison. Project management experience. Regulated industry experience.
- Bachelor degree in Engineering/ Physics or related discipline
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales