Validation Engineer

Collins Mcnicholas Recruitment Hr Services

Sligo

Our clients, a leading Medical Device company in Sligo, are looking to hire a Validation Engineer on a 12 month contact initially. Responsibilities: Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of 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/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation 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 production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Requirements: 3 years plus validation experience in medical device plastics processing, moulding or assembly operations. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. 2 year 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. A minimum of 3 years’ experience in a cGMP regulated environment. For more info contact Mark on 071 914 2411 or e mail mark.whelan@collinsmcnicholas.ie, See all our jobs at www.collinsmcnicholas.ie.

3387 days ago