We are looking for a dynamic CSV Engineer for a contract with a leading medical device client in Galway.
Note: No sponsorship will be provided for this contract role.
A validation Stamp 1 G or Stamp 4 is required at minimum.
Previous Medical Device experience required.
Prepare all lifecycle documentation required such as Functional Specifications, software design specifications, calibration specifications and other associated documentation required for equipment and systems.
Development and execution of validation documentation such as IQ/OQ/PQ, Test Method Validations
Test Method development, Development or modification of Test Method Validation protocols and reports
Development or modification of validation packages, design plans, and risk management deliverables (e.g.
FMEAs).
Ensure software is controlled and stored as per validation procedure guidelines.
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Work with Quality department to ensure all validations are in line with validation standards.
Work with key stakeholders on all project deliverables.
Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.
Qualifications
Bachelor's degree in Life Science, Engineering, or closely related discipline is required
Previous Research & Development experience within the medical device industry is advantageous.
3-4 years of Equipment and CSV experience within the medical device industry
Excellent communication, team and organisational skills required.
Ability to use own initiative and be proactive in the management of assigned tasks to set and meet deadlines.
Ability to work co-operatively and effectively with others to establish and maintain good working relationships.
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