IRL : Ireland
We are currently looking for a Process and Equipment Engineer to design, develop, implement and support of the New SiHy manufacturing systems.
Principle Job Responsibilities/Outputs :
§ Participate in design reviews for integrated systems
§ Participate in Level 1 and 2 controls system design reviews
§ Ensures documentation addresses risk based commissioning, verification and validation.
§ Works with Lead Quality / Validation Engineer to execute appropriate verification activities
§ Identify, design, and develop equipment innovations and improvements. .
§ Use appropriate engineering techniques to manage projects, gather and analyse data e.g. six sigma methods.
§ Prepare, maintain and communicate project plans to relevant stakeholders.
§ Prepare appropriate documentation for equipment and system upgrades.
§ Install and validate equipment and automation systems .
§ Implement improvements under the quality system change control mechanisms.
§ Write documentation and SOPs/ WIs associated with equipment or process systems as required.
§ Present technical data to internal/external audit and inspection groups.
Bachelors in Engineering preferred disciplines are mechanical, chemical, industrial.
A minimum of 6 years in technical role in high volume manufacturing environment.
Six sigma experience an advantage
Demonstrated problem solving skills – able to collect data, consider alternative approaches and identify the best course of action.
Medical device and/or pharmaceutical industry experience preferred
Experience working in a validated environment with strong discipline in change control is preferred.
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