* Engineering ( Production/Process Dev/Manufacturing)
Our Client, a leading Medical Device company based in Clare, is seeking a Manufacturing Technician to join their team. The Manufacturing Technician will manufacture products in compliance with all quality and safety requirements, provide manufacturing support to process & product development, support process improvements, and support validation activities within the company.
Responsibilities include but are not limited to:
* Manufacture of products both onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.
* Provide Manufacturing support to R&D to develop and improve process and product development projects.
* Creation, update and review of documentation including Batch records, procedures, etc.
* Ensure all items of equipment are maintained following the maintenance and calibration procedures and schedules.
* Ensure all health, safety and environmental requirements are met.
* Track and report progress across projects by reviewing schedules and due dates, identifying risks and implementing contingency plans.
* Support the Quality Management System through resolution of NCR, NCM's and CAPAs ensuring effective solutions are implemented.
* Stock and inventory management using the ERP system.
* Support Validation Activities including execution of protocols for equipment and process validations.
* Review and contribute to supplier process validation and risk management activities.
* Introduce, assess and approve process changes ensuring product impact is appropriately considered.
* Provide support during internal and external audits.
* Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.
* Carry out process and safety risk assessments, and pFMEAs.
* Communicate effectively with all Internal & External Stakeholders.
* Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments.
Job requirements
* Minimum 2 years industry experience in GMP regulated environment.
* Relevant Level 7/8 qualification in Science/Engineering.
* Previous experience with Bio Materials would be advantageous.
* Experience working in a Good Manufacturing Practices environment.
* Good planning and organizational skills.
* Excellent communication, interpersonal and presentation skills.
* Ability to work both independently and as part of a team.
* Ability to manage multiple projects and prioritize workload effectively to meet project deadlines.
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