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Team Horizon is seeking a Validation Engineer for a 12-month contract at our client’s manufacturing facility in Sligo.
Why you should apply:
* Exciting opportunity to join a global pharmaceutical company and be part of a diverse and experienced team.
What you will be doing:
* Ensure all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
* Coordinate, direct, and actively participate in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
* Generate and maintain Validation Master Plans.
* Generate and maintain Project Validation Plans.
* Create validation plans, protocols, and final reports adhering to cGMP standards.
* Review and approve all protocols and final reports.
* Manage the validation change control process.
* Adhere to and support all EHS & E standards, procedures, and policies.
What you need to apply:
* 3rd level qualification in a relevant engineering or scientific discipline.
* Minimum of 5-10 years’ experience in a cGMP regulated environment.
* Good understanding of regulatory requirements.
* Experience in Process validation (PPQ) in API or drug product, and managing validation events / Non-Conformances during PPQ.
* FUE qualification essential (preferably API). Experience with fast-paced projects. Understanding of ASTM E risk-based qualification.
* Good understanding of Critical Process Parameters / Non-critical process parameters and their relationship with instrument calibration tolerances and PPQ test criteria.
* Ability to collaborate with Engineering and other stakeholders to understand validation requirements.
* Ability to respond quickly to problems during validation.
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