What you need to know
A leading medical device company that manufactures high-value injection moulded packaging and components are currently seeking an experienced, committed, and diligent Senior Validation Engineer to join their team.
As a Senior Validation Engineer, you will report directly to the Quality Manager and be responsible for supporting all validation activities associated with the qualification of tooling and instruments. You will be involved in helping the company successfully introduce new products and will have a direct impact on the company’s new product introduction goals.
The company have an ambitious growth strategy, is currently extending its cutting-edge manufacturing facility in Co. Longford and are hiring a Senior Validation Engineer due to the continued expansion of the business.
This is a permanent role with an excellent salary, package, learning and career development support and genuine opportunities to progress your career.
Your new job
Duties & responsibilities:
Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific/technical knowledge.
Implementing solutions to sustain and improve the QMS.
Support the compliance of ISO 13485 and ISO 14001 systems standards.
Take an active role in change controls ensuring that all changes conform to validated processes and are effectively identified and implemented.
Generation of risk assessments, covering cleaning, validation, and process.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Supports GMP and regulatory audits.
Prepare and deliver training modules to junior members of staff when required.
Perform data analysis and make informed decisions reached via data analysis.
Support continuous improvement through Lean Six Sigma methodologies.
Execution and development of change controls.
Perform root cause analysis of system failures, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.
Implement CAPAs through the change management system.
Participate/lead cross-functional teams including liaising with vendors on projects.
What are we looking for?
A third-level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
Experience in statistical analysis (Minitab) / SPC / validations.
Strong analytical capabilities with the ability to analyse data and make accurate decisions.
Outstanding attention to detail, coupled with the ability to challenge assumptions in a professional manner.
Strong knowledge of ISO 13485 and ISO 14001 Quality Management Systems.
Demonstrable track record of successfully writing and executing validation protocols.
Excellent interpersonal, communication, influencing, and facilitation skills.
A minimum of 3 years experience as a Validation Engineer within a regulated and dynamic manufacturing environment.
Strong communication skills, oral and written, with the ability to explain complex ideas and theories concisely.
A strong team player who can work well with others in cross-functional teams.
Excellent time management skills and the ability to prioritise tasks to meet tight deadlines.
Committed to supporting, developing, and mentoring junior member of staff when required.
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