3x Validation Engineer positions
2 - Permanent
1- 12 Months FTC

Location - Westport

Force recruitment have partnered with one of the top pharmaceutical manufacturers who is currently looking for 3 validation engineers for their site in Westport, who will coordinate the development and maintenance of the site validation program and ensure and external regulatory, quality, and compliance requirements are met.

Responsibilities:

• Coordination / direction and active participation in the validation of site Facility, equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance/execution of the Site Validation Master Plan, Project Validation Plans and schedules
• Generation of validation protocols and final reports to cGMP standards.
• Generation of validation investigations and implementation of corrective actions.
• Creation, review and approval of various quality documents and test data.
• Management of validation exception events and change control processes.
• Maintenance and tracking of validation equipment, if applicable.
• 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.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Qualifications:

• Qualification and/or degree in engineering or scientific discipline.
• 3 years plus validation experience in pharmaceutical, diagnostics or medical device industry
• 3 years plus of knowledge of cGMP and regulatory requirements relating to pharmaceutical, diagnostics or medical device industry.
• Strong communication (written and oral), presentation and troubleshooting skills required
• Effective interpersonal and organizational skills