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Validation Engineer

Job Title: Validation Engineer
Contract Type: Contract
Location: Galway
Industry:
REF: 88579
Job Published: about 1 year ago

Job Description

Contact: Anne Gough
Email: anne@hero.ie
Telephone: 091730022 / 0860449473

Validation Engineers
Our client, a large medical device company in Galway are currently looking to recruit Senior Validation Engineers, Validation Engineers and Validation Technicians for their Galway site, on a contract basis. The Validation Engineering Galway jobs will be responsible for the technical leadership and development of a validation project team; the assignment of validation activities to the validation project team; manage all aspects of Equipment & computerised system validation for any software systems used in the manufacture of medical devices.

Key Duties:
  • Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
  • Prepare software design specifications and associated documentation for equipment and systems.
  • Ensure software is controlled and stored as per validation procedure guidelines.
  • Work with Quality department to ensure equipment validations are in line with plant validation standards.
  • Ensure regulatory compliance with European and US software validation requirements.
  • Ensure Computerised system validation procedure(s) is (are) kept up to date and maintained.
  • Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
  • Provides software validation/compliance guidance and training to staff across various functions as required.
  • Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues.
  • Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work.
  • Creates and executes IV/OT documents and reports, reviews FS's and provides direction and support on validation plans.
  • Actively pursues continuous improvement
  • Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.
  • Generates quotations, concepts and business cases for new and upgrade software systems.


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 further information on Senior Validation Engineers Galway please contact Anne Gough on 091730022 / 0860449473 / anne@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie

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