Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Biopharmaceutical client based in Sligo on an initial 12-month contract (with potential to extend).
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.
Primary 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.
Education and Experience:
* 3rd level qualification in a relevant engineering or scientific discipline.
* A minimum of 3-5 years’ experience in a cGMP regulated environment.
* A good understanding of regulatory requirements.
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