Validation Engineer

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

Equipment Validation Engineer opportunity in Fermoy :

Interested please reach out today for details on this 12 month contract.

This is not a CSV role, it will suit someone with Equipment and Process Validation experience gained in a high volume manufacturing enviornment.

• Own and support validation activities in a Medical Device regulated environment.
• Responsible for assigned Process / Equipment / Facility / Utility / Software and Computer System Validation as assigned.
• Generate Validation Plans, Protocols and Reports in support of assigned validation activity.
• Resolution of Problems encountered during validation.
• Ensure Consistency in validation/qualification approach across systems and projects.
• Provide guidance and direction in the preparation and execution of validation activities.
• Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
• Maintain Validation system including conducting Periodic Reviews.
• Participate in change control processes for manufacturing Process / Equipment / Facility / Utility / Software and Computer System modifications.

Quality:

• Assure ongoing compliance with quality and industry regulatory requirements.

Health & Safety:

• Ensure compliance with Health & Safety Legislation and Regulations.

MEASUREMENTS:

• Timely and accurate completion of Validations.
• Compliance with regulatory Standards and requirements.

PERSONNEL SPECIFICATIONS

• Qualifications and Experience:

• QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
• Experience in working within a Medical Device Manufacturing / Pharmaceutical Environment.
• Minimum of 1 year Quality Assurance / Regulatory affairs experience.
• Experience of supporting or completing Process / Equipment / Facility / Utility
• Experience in statistical Analysis / DOE and DMAIC methods.