Job Description

Validation Engineer - Kerry

An opportunity is now available for a Validation Engineer experience with the e-validation platform Valgenesis a significant advantage with duties to include

• Review of all IOQ documentation generated by C&Q vendor.
• Preparation, execution and summary reports from PQ stage onwards for a full suite of equipment and instruments required for an aseptic fill finish facility incorporating Filling Line, Lyophilisers, Clean Utilities, Visual Inspection, QC Laboratories, Warehousing.
• Support and review of documentation from Calibrations and Thermal Mapping Vendors.

Responsibilities:

• Evaluation of validation requirements including areas of new equipment, change controls, new requirements.
• Monitor status of projects and get updates where required, from a validation perspective.
• Provide support to ensure that validation status reports are maintained through the issuing of monthly reports and regular validation group meetings.
• Liaise with project managers to ensure project schedule is adhered to.
• Assessment of current practices to ensure compliance with cGMP requirements.
• Review/Implementation of procedures, reports, results etc. for compliance.
• Review/ Implementation of both global and AICL, CSV documentation.
• Responsible for the coordination of SDLC Documentation.
• Review and approval of all project’s validation protocols plant wide.
• Review and approval of project change controls.
• Provide input into the development of company validation standards.

Arcadis | DPS Group is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.
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