Manufacturing Engineer
CREGG Recruitment is seeking a highly skilled Manufacturing Engineer for a permanent role in Shannon. The ideal candidate will drive manufacturing process improvements, scale-up production, and ensure regulatory compliance in a medical device or pharmaceutical environment.
Brief Job Description
As a Manufacturing Engineer, you will be responsible for leading the procurement, installation, and commissioning of new manufacturing equipment, optimizing workflows, and ensuring regulatory compliance. You will collaborate cross-functionally to manage the transition of processes from R&D to production and drive continuous improvements across manufacturing operations.
Roles and Responsibilities may include (but aren't limited to);
* Lead the selection, procurement, and installation of new manufacturing equipment to support scale-up and commercial production.
* Collaborate with suppliers to qualify new equipment, ensuring compliance with design specifications and regulatory standards.
* Support the transition of manufacturing processes from R&D to production.
* Conduct pFMEA to identify risks and implement controls to improve manufacturing processes.
* Develop and execute equipment qualification protocols (IQ/OQ/PQ) and integrate them into overall process validation.
* Troubleshoot complex process issues and develop robust solutions.
* Track and report on project activities, identifying risks and implementing contingency plans.
* Optimize manufacturing workflows and identify opportunities for process improvements.
* Provide mentorship to junior engineers and technicians.
* Ensure compliance with health, safety, and environmental regulations.
* Ensure compliance with medical device regulations, including FDA and ISO 13485.
Qualifications/Skills Sought;
* Bachelor’s or Master’s degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
* Minimum 3-5 years of experience in manufacturing engineering, preferably within the medical device or pharmaceutical industries.
* Strong expertise in process validation and equipment qualification in regulated industries.
* Experience with manufacturing processes involving powders, particle processing, granulation techniques is highly advantageous.
* Knowledge of FDA guidelines and ISO 13485 standards.
* Proficiency in lean manufacturing, Six Sigma, and other process improvement methodologies.
* Strong technical acumen with the ability to solve complex technical problems.
* Excellent communication, organisational, and project management skills.
Contact Information
For a confidential discussion about this opportunity, please contact Brendan at 086 1772 380 or email brendanmcmahon@cregg.ie
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