Validation Engineer Contractor

1 week ago

Sligo, Sligo, Ireland Team Horizon Remote Work Freelance Full time

Social network you want to login/join with:
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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