Manufacturing Process Validation Expert
Job Description:
We seek a seasoned Manufacturing Engineer to join our team in Galway, Ireland. This role involves supporting an upcoming project by validating manufacturing processes, updating quality systems, and remediating documentation.
Key Responsibilities:
* Analyze specifications and performance requirements for processes, products, materials, or equipment.
* Under broad supervision, compile and analyze operational, test, and experimental data to establish performance standards for new products or processes.
* Summarize, analyze, and draw conclusions from test results leading to effective technical resolutions.
* Troubleshoot new products or processes while working closely with product development teams.
* Continuously drive improvements in process design, layout, and operational performance.
* Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements.
* Actively promote and participate in cross-functional teamwork environments.
* Evaluate new equipment, processes, or chemicals for environmental impact or effects.
* Comply with all regulations governing quality systems.
Requirements:
* Engineering or Quality degree with 2-3 years' relevant industry experience.
* Background in remediation, process validation, CAPA, and NCRs.
* Strong technical writing and documentation skills.
* Knowledge of 21 CFR Part 820 and ISO 13485.
Benefits:
* Competitive employee compensation package.
* Pension contributions.
* Health insurance.
* Paid public holidays.
Location: Galway, Ireland | Onsite.