Job Description
Senior Validation Engineer Consultant
Our client, a world class Medical Devices manufacturer based in Galway, seeks a Senior Validation Engineer who will lead, excute and maintain all validation and associated documentation for equipment on a consultant basis.
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.
This is a contractor role, located in Galway.
Responsibilities for Senior Validation Engineer Consultant:
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 procedures are kept up to date and maintained.
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 upgarde software systems.
Requirements for Senior Validation Engineer Consultant:
HETAC Level 8 qualification in Science/Engineering or Quality.
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.
Experienced in drafting, executing and reviewing validation documents (IQ/OQ) from Functional specifications for automated equipment/software applications.
Assessing revalidation strategy for existing equipment and process, and quantifying level of testing required.
Assessing revalidation 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
Key words: Validation Engineer, Validations, IQ, OQ, PQs, equipment engineer, NPIs, New Product Introduction, Project Management, Six Sigma, Galway, Clare, Mayo, Athlone, Connaught, Ireland.