Are you a Manufacturing Engineer with strong problem solving & validation skills? This could be the perfect role for you!
This company is a leader in medical devices spaces based in county Waterford!
Job Skills & Experience:
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / email@example.com
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Qualifications and Knowledge
Crest Solutions have an open position for a Validation Engineer to join our team.
In the Validation Engineer role, you will be required to support capital projects/equipment qualification, new product introductions and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems and processes. The following activities will be included as part of your role:
Designing, executing and reporting on validation studies for equipment, systems and processes.
Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
Providing technical interpretation and guidance of current US FDA and EU validation requirements for solid dose manufacture, aseptic processing, lyophilisation, sterilisation and depyrogenation
Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
Maintaining validation documentation through the validation lifecycle
Participation in external regulatory inspections
Requirements & Qualifications
Why join Crest Solutions?
In Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. As part of the Crest Solutions team, you will be exposed to, and have the opportunity to work with, the latest cutting-edge technologies. The experience you gain in Crest Solutions will be multi-faceted.
This role also includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme
A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment
A structured approach to professional development opportunities with an educational assistance programme
Grange Castle, Ireland
Time TypeFull time
2 days ago