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Senior Software Validation Engineer

Location Larne, County Antrim
Sector
Job type Permanent
Salary £40000 - £45000 per annum
Published about 2 months ago
Start date ASAP
Contact Jamie Donnelly
Job ref JD5321_1598272340

Job description

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.

The Role

  • 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.

Requirements

  • 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

In return

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.donnelly@staffline.co.uk 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.

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