Senior Validation Engineer

PE Global is currently recruiting a Validation Engineer for a 12 month contract, with a leading multi-national client based in Limerick.

This is initially a 12 month contract position.

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.

Duties of the role/Responsibilities

• 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/Experience

Essential:

• A Bachelor’s degree from accredited college
• Minimum 3 years in a Validation within the Medical Device/ Pharmaceutical industry.

Desirable

• Be very familiar with the relevant regulatory standards applicable to the manufacture of Class III medical devices to Global markets.
• Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
• Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
• Ability to demonstrate standards of leadership – Managing Complexity/CredoValues/ Innovations/Customer focus.
• Flexible
• Team Player
• Good Influencing Skills
• Project Management Skills
• Good generalist
• Good communication skills

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up to date CV to chloe.slingsby@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***