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Team Horizon is seeking a Validation Engineer Team Horizon for an 18 Month contract on behalf of our client, a leading Biopharmaceutical manufacturer in the West of Ireland.
Why you should apply:
* Opportunity to cooordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met
* Work with a diverse & talented team on exciting projects
What you will be doing:
* Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
* Generation of validation and qualification protocols and final reports to cGMP standards.
* Generation of validation investigations and implementation of corrective actions.
* Creation/Review/Approval of various qualification documents and test data.
* Management of validation, exception event, and change control processes.
* Maintenance and tracking of Engineering equipment, if applicable.
* Completing all required training before executing a task.
* Documenting all activities in line with cGMP requirements.
* Updating of Engineering procedures, job instructions and forms to reflect current best practices.
* Performing cross training within the team and training of new team members.
* Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
* Coordinating activities to maximize the effectiveness of all of the team members.
* Maintaining the overall cGMP compliance of the engineering areas.
* Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
* Required to work as part of cross functional internal and corporate teams.
* Provide reports, schedules and timelines for qualification projects in progress to engineering manager.
* Liaise with vendors on system definition and design qualification.
What you need to apply:
* 3 years plus validation experience in medical device plastics processing, moulding or assembly operations.
* A minimum of 3 years’ experience in a cGMP regulated environment.
* 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry.
* 2 years plus of experience of validating in a highly automated environment.
* Strong communication (written and oral), presentation and troubleshooting skills required.
* Effective interpersonal and organizational skills.
* Ability to work well both independently and in a team environment.
* Capable of prioritizing work and multitasking.
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