Validation Engineer

PE Global; Cork; On-site; EUR 50,000 - 70,000; Full time

Job summary

PE Global is recruiting a Validation Engineer for a leading medical device company in Cork on a 6–12 month contract. You will own and support validation activities for processes, equipment, facilities, utilities, software and CSV within a GMP-regulated site.

The role requires 3–5 years in validation engineering, a Level 8 degree in a relevant field, and 1 year QA/regulatory experience. Visa sponsorship is not available.

Qualifications

• Level 8 Degree in a science/engineering field
• Experience in medical device manufacturing or pharmaceutical environments
• 3–5 years in a validation engineering role
• Minimum 1 year QA/Regulatory affairs experience
• Experience in validating processes/equipment/facilities/utilities/software/CSV
• Experience in statistical analysis/DOE and DMAIC
• GAMP 5 experience preferable but not essential

Responsibilities

• 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.
• Assure ongoing compliance with quality and industry regulatory requirements

Skills

Validation

GMP knowledge

Statistical analysis

DOE

DMAIC

CSV

Statistical methods

Education

Level 8 Degree in Science/Engineering

Job description

PE Global is currently recruiting for a Validation Engineer on behalf of a leading medical device company based in Cork. This is an initial 6-12 month contract role.

Responsibilities:

• 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.
• Assure ongoing compliance with quality and industry regulatory requirements.

Education and Experience:

• Level 8 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
• Experience in working within a Medical Device Manufacturing / Pharmaceutical Environment.
• 3-5 years experience in a validation engineering role
• Minimum of 1 year Quality Assurance / Regulatory affairs experience.
• Experience of supporting or completing Process / Equipment / Facility / Utility / Software / Computer System Validation.
• Experience in statistical Analysis / DOE and DMAIC methods.
• Experience in using the GAMP 5 approach is preferable but not essential.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***