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Validation Engineer

2 weeks ago

Sligo, Sligo, Ireland Team Horizon Full time
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.
Assign resources to qualification activities.
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.