***Validation Engineers for 2 sites in Dublin 13*** Med Dev and Pharma 2 new perm roles open for Validation Engineers with 3+ years’ experience. Both roles are with progressive, rewarding and challenging employers offering exciting and progressive career paths. If you are interested in hearing more about both, send your CV to me and Chloe O’Brien at email@example.com and we can arrange a confidential call back.
Out client is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Their employees are at the core of their success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day.
The Validation Engineer performs activities to support commissioning, qualification and validation activities in the commercial manufacturing plant in Baldoyle, Dublin 13, Ireland.
The responsibilities of the incumbent will include performing utility and equipment qualification, process validation, cleaning validation, re-qualification and any other qualification/validation requirements.
- As a Validation Engineer you will be tasked with the following
- Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and cleaning in compliance with European cGMP and GAMP standards.
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Generation of validation protocols and final reports to cGMP standards.
- QA support for validation investigations and implementation of corrective actions.
- Creation/Review/Approval of various validation and qualification documents
- Management of validation, exception event, and change control processes.
- Documenting all activities in line with cGMP requirements.
- 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.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Qualifications for the Validation Engineer role
- Bachelor`s Degree in Engineering or equivalent combination of training and experience.
- 3 years plus of knowledge of cGMP and regulatory requirements, preferably relating to the pharmaceutical industry.
- 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.