Science, Pharmaceutical & Food
Equipment Validation Engineer
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.
- 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 firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***