Validation Engineer - Pharmaceuticals - Sligo, Ireland - 18-Month ContractLocated 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, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports
Responsibilities:
- 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 maximise 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.
Requirements:
- Extensive validation experience in medical device plastics processing, moulding or assembly operations.
- Experience in a cGMP regulated environment.
- Knowledge of cGMP and regulatory requirements relating to the medical device industry.
- Experience of validating in a highly automated environment.
- Strong communication (written and oral), presentation and troubleshooting skills required.
- Effective interpersonal and organisational skills.
- Ability to work well both independently and in a team environment.
- Capable of prioritising work and multitasking.
If this role is of interest to you, please apply now!
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