Validation Engineer

I am keen to speak with Validation Engineers with a background in Regulated Manufacturing utilizing Automated Equipment.

 

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.

 

We currently have need for three Engineers for Fixed Term Contracts (12 Month) (Employed directly by the company) – 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:

• 12 Month Fixed Term Contract (Employed directly by company)
• €55k – €65k Basic (Negotiable)
• Contract Completion Bonus (10%)
• Health Insurance (VHI)
• Paid Annual Leave
• Parking
• Canteen
• Signing Bonus (€)

 

Role:

 

The purpose of the position is to provide Quality Engineering services for the Plant Value Stream and so contribute to the growth and profitability of the business. You will develop and implement Validation Plans/Protocols/Reports, Risk Assessments and lead Quality Engineering Project’s and Compliance activities in the business.

 

Duties:

• Develop Master Validation Plans
• Develop and complete DV/IQ/OQ/PQ protocols
• Contribute to the development of FAT/SAT protocols
• Execute Validation Protocols, root cause deviations and generate validation reports
• Contribute to product specifications / drawings / quality plans in conjunction with NPD personnel
• Provide QE support for New Product Development (NPD) projects
• Process Risk Management / FMEA
• Complete internal audits per the audit schedule
• Co-ordinate and implement process capability analysis on sealing processes
• Complete CAPA, Non-conforming material rejection and complaint investigations
• Lead Production System assessments for the department

 

Experience:

 

• Degree in Engineering/Science Discipline
• 5 Years’ experience in Medical Device Industry utilizing Automated Equipment
• Experience in statistical analysis / SPC / validation of 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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