Validation Engineer

Description:

PE Global is currently recruiting for a Validation Engineer on behalf of a leading pharmaceutical company based in Sligo. This is a fixed-term 12 month contract role.

Purpose:

To coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements. Co-ordination, implementation and active participation in the site Validation Program.

Responsibilities:

• Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
• Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance of the Validation Master Plans.
• Generation/maintenance of Project Validation Plans.
• Generation of validation plans, protocols and final reports to cGMP standard.
• Review / approval of all protocols and final reports.
• Management of validation change control process.
• Adheres to and supports all EHS & E standards, procedures and policies
• Reports to Validation Team Leader.

Education and Experience:

• 3rd level qualification in a relevant engineering or scientific discipline.
• A minimum of 5-10 years’ experience in a cGMP regulated environment.
• A good understanding of regulatory requirements.
• Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
• Strong communication skills both verbal and written are required for the execution of this role.
• Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
• This position impacts on product quality and technical performance as well as manufacturing operations.
• Close contact with internal and external auditors, e.g. FDA, HPRA.
• Provide technical leadership to functional areas and collaborates with key stakeholders.
• Is a site SME on validation issues and provides guidance on same.

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***