Brightpath Recruitment Engineering & Life Sciences is currently seeking Computer Systems Validation Engineer for Dublin, Limerick and Galway. These are permanent positions.
Our client works in the Pharma, Medical Device, Healthcare and Food and Beverage Sectors with clients who require high level expertise in industrial IT integration and regulatory compliance.
As the Software Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.
This company offers employees extensive opportunities for professional and personal development and these include:
- Career growth: Through a clear Career Development Programme for all staff.
- Technical development: The opportunity to work on highly technical projects with an excellent client base.
- Comprehensive benefits package: An excellent benefits package tailored to the specific needs of staff.
- Lifelong learning: Staff are encouraged to avail of additional training & development through in-house training and there is also a support programme available to employees completing additional training or educational courses.
- Travel opportunities: The diverse range of projects you could work with means there are travel opportunities available for employees not only within Ireland and the UK but internationally.
- Contributing to the preparation and review of the Validation Master Plan
- Generation of all validation strategies and deliverables
- Development and maintenance of internal validation policies and
- Auditing of internal projects against internal validation policies and procedures
- Managing the preparation, review and issuing of validation protocols and reports
- Generating validation documentation
- Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems.
- Establishing, implementing and directing validation and revalidation activities.
- Working directly with a cross functional team to define inputs and requirements to the MVP.
- Reviewing and managing change control forms for Validation/Compliance implications.
- Conducting routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
- Updating existing quality documentation related to validation activities.
- Generating Standard Operating Procedures (SOP’s)
- Identifying training requirements in support of validation.
- Conducting Risk Assessments.
- Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device.
- Execute test cases per protocol and document the results.
- Participate in the development and review of software requirements.
- Contribute to the design and implementation of software validation processes on projects.
- Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process.
- Provide technical direction and hands-on assistance for testing projects.
- Reviewing vendor validation documentation
- Co-ordinating the validation activities (including the vendors)
What you need to succeed:
- Bachelor's Degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline
- 2 years’ experience as a Validation Engineer (mainly computer validation) in the Pharma industry
- Software engineering experience in a regulated industry: FDA 21 CFR 820, the Quality System Regulation, ISO 13485, and IEC 62304 are required.
- Experience of GxP Computerised Systems would be an advantage
- Excellent understanding of GAMP5 Guidelines, validation concepts and documentation.
- Excellent communication skills, including ability to advise and influence.