Validation Engineers

Hero Recruitment

Galway

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 Engineer s, 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. Please Note: HERO Recruitment will not forward your details to any company without your prior approval. This job originally appeared on RecruitIreland.com.

2443 days ago