Equipment Validation Engineer

The role:

PE Global is currently recruiting for an Equipment Validation Engineer on behalf of our client based in Limerick. This is an initial 12 month contract role.

Responsibilities:

• To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Validation Policies and Procedures are addressed.
• Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance
• Continuous Learning/Managing Risk Resolves & manages technical operational problems in area of expertise
• Suggest and sometimes may implement innovation and continuous improvement within the Validation process
• Implements initiatives in the Validation Process that will deliver customer value at lowest cost
• Facilitates successful team behaviour within Quality Systems and across functional areas
• Manages relationships externally and internally.
• Builds cross functional and cross-departmental support, fostering overall effectiveness
• Fosters harmony within Quality Systems.
• Influences and persuades so as to bring about technical and process improvements.
• Ensure accuracy and maintenance of the Validation Master List.
• Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
• Ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
• Ensure that all validation activities are carried out and reported in a timely manner.
• Ensure compliance through assisting in audits.
• Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Policies and Procedures.

Education and Experience:

• A Bachelor’s degree from accredited college
• 2-3 years in a Quality function within the Medical Device/ Pharmaceutical industry.
• Be very familiar with the relevant regulatory standards (F.D.A. – Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.
• Experience working in a lab with lab equipment qualification experience.
• Must have lab equipment install/validation experience.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

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