My client is seeking a highly skilled and motivated CSV Engineer to join their team in Cork. In this role, you will be responsible for ensuring the validation and compliance of computer systems used in the development, manufacturing, and quality assurance of our medical devices.
Key Responsibilities:
- Develop, execute, and maintain CSV protocols and reports, including IQ, OQ, PQ, and validation summary reports.
- Ensure that all computer systems used in the manufacturing, quality control, and R&D environments comply with relevant regulatory standards (e.g., FDA, ISO 13485).
- Collaborate with cross-functional teams to ensure seamless integration and validation of new systems and software.
- Perform risk assessments and impact analyses to determine the scope of validation activities.
- Provide guidance and training to other departments on CSV-related topics.
Skills & Qualifications:
- Bachelor's degree in Engineering or a related field.
- 3+ years of experience in computer system validation within the medical device, pharmaceutical, or biotech industry.
- Excellent problem-solving skills and attention to detail.
- Strong communication skills, with the ability to work effectively in a team environment.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
