Our client, a leading biopharmaceutical company, is keen to hire a Validation Engineer to join their team in Sligo on an initial 12-month contract. The Validation Engineer will carry out the development and maintenance of the site validation program, ensuring all regulatory, quality, and compliance requirements are met.
Major Responsibilities (Full job description available on request):
- 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.
- Coordination/direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Creation/Review/Approval of various validation and qualification documents.
- Management of validation, exception event, and change control processes.
- Comply with all company EHS policies and procedures and demonstrate EHS best practices in all work activities ·
- Degree in engineering or scientific discipline.
- 3 years plus validation/Quality experience in sterile/aseptic environments especially in the commissioning and qualification area.
- 3 years plus of knowledge of cGMP and regulatory requirements 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.
For a confidential discussion and more information on the role, please contact Sarah Flynn