Validation Engineer

I am keen to speak with Equipment / Process Validation Engineers with a background in Regulated Manufacturing.

 

One of Ireland’s leading Medical Device Manufacturers this challenging role offers a Competitive Package at this award-winning facility.

 

ISS Ltd is also happy to offer a Signing Bonus (€) to the successful candidate – APPLY TODAY

 

Validation / Validation Protocols / Equipment Validation / Process Validation / DV / IQ / OQ / PQ Protocols / Quality Engineering / Automation / Automated Manufacturing / GMP / ISO 13485 / FDA / Medical Device Manufacturing / Mayo / Ireland

 

Job Title: Validation Engineer

Location: Co. Mayo

Reporting To: Validation Project Manager

Package:

• Perm / Full Time
• €55k – €60k Basic (Negotiable)
• Annual Bonus (7.5%)
• Health Insurance (VHI)
• Pension
• Paid Annual Leave
• Parking
• Canteen
• Signing Bonus (€)

 

Role:

 

The purpose of the position is to provide Quality Engineering (Validation) Services for the County Mayo Facility. You will support validation projects and any other QA activities on site as required.

 

Projects will include supporting the qualification of new equipment and up-grades to existing equipment.

 

Key Stakeholders: Engineering, Manufacturing, Supply Chain Management and Product Development

 

Duties:

• Complete Process and Equipment Validation including FAT, SAT, IQ, OQ, PQ protocol development, implementation, and report completion
• Conduct Risk Management / FMEA / Statistical analysis
• Conduct process capability assessment as part of process changes management
• Implement process control and ensure process capability is maintained and identify opportunities for process improvement
• Conduct CAPA analysis to determine root cause and complete problem resolution.
• Ensure process changes are implemented per change control procedures

 

Experience:

 

• Degree in Engineering/Science Discipline
• 3-5 Years’ experience in Medical Device Industry utilizing Automated Equipment
• Ability to participate in cross functional teams

 

Personal Characteristics:

 

• Communication: Excellent communication and presentations skills, both written and oral – ability to present forecasting, capacity, and other relevant Quality data in a clear and concise manner to the Business Unit Planners and where required, to senior management
• Planning & Organising: Able to plan activities and tasks
• Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
• Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
• Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles

 

If you would like to be considered for this opportunity, follow the links below and send me your CV.

 

Key Words: Validation / Validation Protocols / Equipment Validation / Process Validation / DV / IQ / OQ / PQ Protocols / Quality Engineering / Automation / Automated Manufacturing / GMP / ISO 13485 / FDA / Medical Device Manufacturing / Mayo / Ireland

 

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