Senior Software Validation Engineer
Senior Software Validation Engineer
Location - Larne, County Antrim
Salary: Highly Competitive
Staffline Recruitment has been retained to recruit a Senior Software Validation Engineer based in Larne, County Antrim.
- Responsibility for all relevant Process / Equipment Validation activities.
- Generation and execution of equipment validation documentation (protocols and reports) and assist in the execution of qualifications such as IQ/OQ/PQ.
- Assist in managing delivery of validation projects
- Author, review, approve and execute validation documentation including protocols, summary reports, procedures, other lifecycle documents.
- Recording and analysis of process data including use of statistical process control techniques.
- Review of vendor prepared/executed commissioning & validation documentation
- Reporting of Validation non-conformances and providing solutions to remediate issues
- Working with cross function departments to ensure solutions are implemented in an efficient and effective manner
- Review of the impact of change on the maintenance of the validated state, including execution of re-validation as required
- Generation of product and process risk assessments (pFMEA) and/or relevant risk based tools
- To ensure that good GMP/QMS standards are maintained at all times.
- Evaluate and verify issues discovered, log probable software defects in defect tracking database.
- Review test data with all team members.
- Develop summary reports for entire tests performed and assign as required.
- Ensure all test methods and data are archived in suitable file archive system.
- Prepare validation and acceptance criteria and evaluate test results to ensure software attains requirements and parameters
- Identify gaps, suggest solutions and lead enhancement to software validation procedures, processes and practices
- Ensure documents and practices attain quality standards and applicable regulatory conformance.
- Min 3 years job-related experience
- Third Level Degree in a Computer Science, Science or Engineering related subject
- Strong communication and technical writing skills
- Experience in applying a risk-based approach in processes / procedures
- Good time management and planning skills
- Ability to work under pressure and to strict deadlines - (this role may necessitate working additional hours and/or shifts as and when required.
- Good organisational skills with the ability to prioritise and work effectively on multiple tasks
You will receive a fantastic package, the opportunity to work for a key player in the industry and the opportunity to develop your career in a supportive environment.
Contact Details & Deadline
To be considered for this position, please forward your CV to Jamie at Jamie.email@example.com at Staffline Recruitment OR call him on 02890323333
The Staffline Specialist Team is a dedicated division within Staffline Recruitment, focused on providing Permanent, Contract & Temporary staffing solutions across; Construction, Engineering, Accountancy & Finance, Financial Services & Insurance, Health & Safety, HR, IT, Sales & Marketing, Senior Manufacturing, Procurement & Supply Chain & Medical, Health & Social Care.
This may not matter to you when you're looking for a new opportunity, but we just wanted to tell you a little bit about Staffline. We know that finding the right job can be challenging and we have the tools and resources to help you succeed. An established recruitment agency since 1983, we offer permanent and temporary job solutions to lots of different clients in multiple sectors in Northern Ireland and Republic of Ireland