Validation Engineer

Equipment Validation Engineer opportunity in Fermoy :

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.