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Senior process validation engineer

Galway
beBeeManufacturing
Validation engineer
Posted: 13 September
Offer description

Manufacturing Engineer Opportunity

We are seeking a Manufacturing Engineer to support an upcoming project. This role will focus on manufacturing process validation, quality system updates, and documentation remediation.


Key Responsibilities:

* Analyse process, product, material or equipment specifications and performance requirements.
* Compile and analyse operational, test and experimental data to establish performance standards for newly implemented or modified products/processes.
* Summarise, analyse and draw conclusions from test results leading to effective technical resolution.
* Troubleshoot new products/process working closely with product development.
* Continually seek to drive improvements in process design, layout and operational performance.
* Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements.
* Actively promotes and participates in a cross-functional teamwork environment.
* Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
* Understands and comply with all the regulations governing the quality systems.


Requirements:

* Engineering or Quality degree with 2-3 years' relevant industry experience.
* Background in remediation, process validation, CAPA, NCRs.
* Strong technical writing and documentation skills.
* Knowledge of 21 CFR Part 820, ISO 13485.


Benefits:

* Competitive employee compensation package.
* Pension contributions.
* Health insurance.
* Paid public holidays.


Location:

Galway, Ireland | onsite

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