Job Description
Our client, a world class Medical Devices manufacturer based in Galway, seeks an experienced Validation Engineer who will lead project validation team, including delegating validation tasks and activities in accordance with validation strategy on site.
The successful candidate will be responsible for the technical leadership and development of a validation project team, while managing all aspects of equipment & computerised system validation for any software systems used in the manufacture of medical devices.
Responsibilities for Validation Engineer, CSV:
Leads cross-functional team relationships and works similarly to lead troubleshooting issues, implementing processes and procedural improvements.
Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work.
Prepare software validation protocols for group and 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 procedures are kept up to date and maintained.
Provides software validation/compliance guidance and training to staff across various functions as required.
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 upgarde software systems.
Requirements for Validation Engineer, CSV:
HETAC Level 8 qualification in Science/Engineering or Quality.
4+ years' experience in a Validation role within regulated industry i.e. medical device, biotech or pharmaceutical manufacturing organization.
Proven track record and performance leading validation teams within manufacturing environment.
Experienced in drafting, executing and reviewing validation documents (IQ/OQ) from Functional specifications for automated equipment/software applications.
Execute validation strategy for existing equipment and process, and quantifying level of testing required.
Please phone Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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