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Lab Equipment and Systems Engineer

Job Seekers Ireland Science Life Science

Job Summary

  • Dublin
  • Permanent
  • BBBH815844
  • May 13, 2022
  • Competitive
Job Description

A Lab Equipment and Systems Engineer is required to join a Device Product Performance group in a global R&D center of excellence.

Responsibilities:

  • Manage all Equipment Installation and Qualification, Computer System Validation (CSV), Preventative Maintenance and Calibration Schedules and ensuring compliance with GDD's Quality Management System.
  • Develop and update documentation relating to equipment use and qualification, in line with Regulatory standards.
  • Basic troubleshooting, maintenance and repair on Lab test equipment.
  • Completing Preventative Maintenance on sustaining activities.
  • Ensure all Data Integrity requirements are met for all lab systems.
  • Maintaining daily communications with Lab team to ensure resolution and proper follow-up.
  • Support the closure of QMS activities in conjunction with Device Development Assurance.
  • Accountable for ensuring operations are fully compliant with EH&S legislation, and corporate requirements and guidelines. Actively promote a positive and engaged EH&SS culture. Self-motivated, results oriented with strong planning and scheduling skills.

Requirements:

  • Degree in Science and/or Engineering with at least 3 years' experience in a GMP or ISO 13485 accredited laboratory
  • The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment
  • Experience of supporting laboratory readiness for inspections and participating in an FDA or HPRA audit
  • Experience of leading and approving laboratory equipment qualification including CSV
  • Strong Technical writing and communication skills
  • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife Duggan
Aoife Duggan
  • Manager | Engineering Recruitment
  • +353 21 2300300
  • aduggan@morganmckinley.com