Team Horizon is seeking a Validation Engineer for a 12-month contract for our client’s manufacturing facility in Sligo.
Why you should apply:
* Exciting opportunity to join a global pharmaceutical company and join 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.
* 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 and maintenance of the Validation Master Plans.
* Generation and maintenance of Project Validation Plans.
* Generation of validation plans, protocols, and final reports to cGMP standard.
* Review and approval of all protocols and final reports.
* Management of 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.
* A minimum of 5-10 years’ experience in a cGMP regulated environment.
* A good understanding of regulatory requirements.
* Experience in Process validation (PPQ) in API or Drug product and experience with managing validation events/Non-Conformances during PPQ.
* FUE qualification essential (preferably API). Experience with working in 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 selection of PPQ test criteria.
* Ability to work directly with Engineering and other stakeholders to understand validation requirements.
* Ability to react to problems quickly during validation.
#J-18808-Ljbffr