Validation Engineer

Validation Engineer - Pharmaceuticals - Sligo, Ireland - 18-Month Contract Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Validation Engineer to join their state-of-the-art pharmaceutical facility. Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, this area breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants, and water sports.

Responsibilities:

1. 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.
2. Generation of validation and qualification protocols and final reports to cGMP standards.
3. Generation of validation investigations and implementation of corrective actions.
4. Creation, review, and approval of various qualification documents and test data.
5. Management of validation, exception event, and change control processes.
6. Maintenance and tracking of Engineering equipment, if applicable.
7. Completing all required training before executing a task.
8. Documenting all activities in line with cGMP requirements.
9. Updating of Engineering procedures, job instructions, and forms to reflect current best practices.
10. Performing cross-training within the team and training of new team members.
11. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
12. Coordinating activities to maximise the effectiveness of all team members.
13. Maintaining the overall cGMP compliance of the engineering areas.
14. Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
15. Required to work as part of cross-functional internal and corporate teams.

Requirements:

1. Extensive validation experience in medical device plastics processing, moulding, or assembly operations.
2. Experience in a cGMP regulated environment.
3. Knowledge of cGMP and regulatory requirements relating to the medical device industry.
4. Experience of validating in a highly automated environment.
5. Strong communication (written and oral), presentation, and troubleshooting skills required.
6. Effective interpersonal and organisational skills.
7. Ability to work well both independently and in a team environment.
8. Capable of prioritising work and multitasking.