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Device Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 02/08/2018
  • Job reference: BBBH14988

Device Engineer

The Device Engineer will be focused on the tech transfer and in process manufacturing of how the device operates through concrete evaluations and validations of current as well as new manufacturing practices or processes with a primary focus on improving productivity, quality, reliability and consistency. This position will execute several functions such as writing standard operating procedures (SOPs), develop process flow, perform root cause analysis, review design documents related to procurement of new devices; perform testing and operation of equipment.

Main design for manufacture responsibility is currently based in the States, that could change over the next 6 months as the company would hope to bring more PD onsite but at the moment it's more in process control of the device.

Responsibilities

  • Responsible for site operations to suggest and implement improvements; This entails completing process simulations and optimization studies and implementing modifications and process installations at the manufacturing level
  • Oversee new manufacturing processes for new products through process validation. Develop process flow for an updated or new process to get a quality product using six-sigma approach
  • Write Standard Operating Procedures (SOPs) and execute equipment installation and operational qualifications, validation report. Supports technical services teams and assist in investigations, root cause analysis, process optimization, maintenance reliability metrics and engineering services
  • Establish reports, charts, and tables based on established statistical methods to drive process enhancements such as tooling changes and in-process testing controls.
  • Provide expertise on specification for processing equipment
  • Working with concept sketches to detailed specifications, suggest material and process options, estimate costs and layout a detailed production design
  • Evaluate, improve and validate current manufacturing practices or processes with an effort for continuous improvement towards productivity, quality, reliability and consistency
  • Initiate a change control for any recommended changes in the process and get approval from the associated departments for the new implementation

Additional Responsibilities

  • Other duties that management may from time to time assign.
  • Write and review deviation and CAPA (Corrective action and preventive action
  • Material and resource management for successful process implementation
  • Review of process related documents

Education

  • Master Degree (MS/MA) Engineering, Pharmaceutics, Industrial Pharmacy, or related field. - Preferred
  • Bachelor's Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 3 years of experience in Industrial Pharmacy or Engineering in lieu of the Master's degree.
  • 2-3 years-experience within a highly regulated environment, preferable pharmaceutical.

Interested?

Do not hesitate to reach out to Jack on 01-6455250 or email your CV to jack.conway-kenny AT experis.ie



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