Job Title:
We are seeking a Manufacturing Engineer to support our expanding operations in Galway.
* Key Responsibilities:
* Cleanroom manufacturing processes: Implement and maintain cleanroom manufacturing processes that meet quality, cost, and delivery goals.
* New Product Introduction (NPI): Lead NPI initiatives from concept to commercialisation, ensuring alignment with regulatory standards.
* Continuous improvement: Develop and implement strategies to optimise efficiency, reduce waste, and enhance process reliability.
* Validation protocols: Prepare and execute validation protocols (IQ/OQ/PQ) and support equipment qualification activities.
* Process documentation: Develop and maintain process documentation, including work instructions, FMEAs, and process flow diagrams.
* CAPAs: Investigate non-conformances and implement corrective actions to ensure product and process compliance.
* Cross-functional collaboration: Collaborate with Quality, R&D, and Production teams to meet project timelines and deliver high-quality products.
* Regulatory compliance: Ensure all activities align with GMP, ISO 13485, and regulatory standards.
Candidate Requirements:
* Degree: Degree in Engineering, Manufacturing, Biomedical, Mechanical, or a related discipline.
* Experience: Minimum 2 years' experience in a regulated manufacturing environment, ideally medical devices.
* Skills and Qualifications: Strong knowledge of GMP, process validation, and manufacturing best practices. Experience in problem-solving tools and excellent communication and cross-functional collaboration skills.