Team Horizon is seeking a Validation Engineer 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 coordinate 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, and 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 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 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 the 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.
#J-18808-Ljbffr