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.