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  • Unit 1, Grandy,
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  • Job reference number:15320565
  • Client ID:RI/rtlane024
  • Posted on:07-FEB-2018
  • Salary:45-50k
  • Location:CLARE


R.T.Lane Recruitment are looking for a Process Engineer with Validation experience and Medical Devices industry experience for a role inClare

Job Summary

Responsible for providing manufacturing engineering services for timely new product introductions to the Clean & Pack Business Unit. Engineering services include Process Development / Validation, New Product Introductions and capacity expansion. The candidate for this role needs to display good leadership capability, strong process validation experience, project management skills to deliver project milestones on time and within budget.

Principal Duties and Responsibilities

  • Validation assessment and validation execution of Final Cleaning, Biological Upgrade and Packaging processes for new product introductions.
  • Establishing process methods which meet performance and quality requirements.
  • Establishing preliminary bill of materials and routers – establish optimal routings.
  • Sorting through options choosing the most appropriate processes.
  • Developing a wide a variety of applications, clean and packaging.
  • Negotiating target completion dates with appropriate personnel from other departments.
  • Developing project plans and schedules for work activities.
  • Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements affecting the make versus buy decision.

Expected Areas of Competence

  • Skilled in writing and execution of Validation protocols, IQ/OQ/PQ.
  • Skilled and knowledgeable in Clean and Packaging Operations and new product introductions.
  • Familiarity with control procedures, such as the Engineering Change Notification and Deviation process, and Engineering Specifications.
  • Familiarity with reviewing engineering drawings for geometric dimensioning and tolerancing.
  • Demonstrates good problem solving skills through the use of quality and statistical tools.
  • Ability to effectively work within a team and cross functionally to expedite completion of critical project tasks.
  • Ability to balance, manufacturing and design requirements to meet licensing requirements
  • Ability to handle project assignments of large scope and complexity and able to prioritize and complete work in a timely manner.
  • Demonstrates good written and verbal communication skills.
  • Competent with Microsoft Office Suite including Project; Statistical Process Control skills.

Education/Experience Requirements

•B.Sc. in Mechanical, Industrial Engineering, or other Engineering Science and/or demonstrated multiple years of Validation experience.

Please call Rachel Lane for more details ono 0225 46969 or send yoru cv to

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