Description
Based in the West of Ireland, excellent opportunity for both contract and perm Validation engineers. Our client, are offering this exciting opportunity to Senior Validation engineers and Validation engineers.
The successful candidates will be responsible managing the equipment and computerised system validation for any software systems used in the manufacture of Medical devices.
Successful candidates will have experience in:
- Drafting validation documents (IQ/OQ) from functional specifications for automated equipment's/software applications
- Executing validation protocols on automated equipment/software applications, compiling reports with all objective evidence
- Reviewing and approval of validation documents
- Raised discrepancies/deviations against protocols and identified resolutions and justifications
- Assessed the impact of changes to software/equipment to determine revalidation strategy of testing
Qualifications and Experience:
Validation Engineer II:
- Min. HETAC Level 8 qualification in Science/Engineering or Quality.
- Minimum of 5 years' experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization.
- Proven track record and performance leading validation teams within manufacturing environment.
Validation Engineer I/Graduate Engineer:
- Min. HETAC Level 8 qualification in Science/Engineering or Quality.
- For an Engineer I: Minimum of 3 years' experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization.
- For a Graduate Engineer: Minimum of 1 year experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization
- Proven track record and performance executing validation activity independently or as part of a team.
Validation Technician:
- Min. HETAC Level 6 qualification in Science/Engineering or Quality.
- Minimum of 3 years' relevant experience in a similar or role
For more information please call me (see below)