Medical Device Validation Engineer (12-Month Contract)

RT.Lane; Fermoy; On-site; EUR 52,000 - 76,000; Full time

Job summary

RT.Lane in Fermoy, Ireland is seeking an Equipment Validation Engineer for a 12-month contract. The role focuses on validating process/equipment/utility systems in a Medical Device manufacturing environment.

You will generate validation plans, protocols and reports, support change controls, maintain GMP compliance, and ensure timely completion of validations. QQI Level 7 degree preferred; 1 year QA/regulatory experience and experience with DOE and DMAIC are desirable.

Qualifications

• Experience in Medical Device Manufacturing or Pharmaceutical environments.
• Minimum of 1 year Quality Assurance/Regulatory affairs experience.
• Experience supporting or completing Process/Equipment/Facility/Utility validation.

Responsibilities

• Own and support validation activities in a Medical Device regulated environment.
• Generate Validation Plans, Protocols and Reports for assigned validation activities.
• Resolve problems encountered during validation.
• Ensure consistency in validation/qualification approaches across systems and projects.
• Provide guidance in preparation and execution of validation activities.
• Maintain Validation system including periodic reviews.
• Participate in change control processes for manufacturing Process/Equipment/Facility/Utility/Software validation.

Skills

Validation experience

GMP knowledge

Statistical analysis

DOE

DMAIC

Education

QQI Level 7 Degree (Science/Electronics/Mechanical/Industrial Engineering)

Job description

RT.Lane in Fermoy, Ireland is seeking an Equipment Validation Engineer for a 12-month contract. The role focuses on validating process/equipment/utility systems in a Medical Device manufacturing environment.

You will generate validation plans, protocols and reports, support change controls, maintain GMP compliance, and ensure timely completion of validations. QQI Level 7 degree preferred; 1 year QA/regulatory experience and experience with DOE and DMAIC are desirable.