Validation Specialist - Medical Device
A leading healthcare who specialise in treatment of disease through an advanced technology, is now looking for a Validation Specialist to come on board.
Joining the Technology Transfer Team you will be working closely with New Product Development Team to support in process validation for New Product Development projects.
You will also be responsible for validation and re-validation of Production Equipment and Processes
* Perform process validation for New Product Development projects.
* Facilitate Design Verification and Validation activities by providing consultation and support to the generation of test protocols and process validation rationales.
* Compose, review and approve all validation documentation associated with processes, equipment (IQ, OQ, PQ), methods, utilities/ facilities and computer systems.
* Conduct equipment installation, operation and performance qualifications.
* To ensure validation and revalidation requirements are identified and implemented and processes and / or equipment remain in a validated state in accordance with company policy and legislative requirements.
* To maintain master validation plan and reports and associated secondary validation documentation.
* To participate in the developments and technical transfer of new products as required.
* Degree level qualifications in an Engineering/Science discipline, or equivalent
* Previous experience within a quality (validation) environment in the biotech/ medical device/ pharmaceutical industry
* Experience in the preparation, review, implementation of validation protocols (IQ,OQ,PQ and PV) will be desirable.
* Previous experience in validation and operational support will be desirable.
* Ability to identify opportunities for process and operational improvements and implement appropriate changes to deliver these benefits.
* Good knowledge of Design Inputs, Verification, Validation, Design Reviews, Design Outputs
* Experience in the Medical Device industry, working to 93/42/EEC and ISO 13485:2003 standards would be desirable.
Key Words: Validation, Design Verification, IQ, OQ, PQ, Master Validation Plan, Process Validation, Tech Transfer, Medical Device, ISO 13485.
Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.
- ISO 13485
- Design Verification
- Process Validation
- Medical Device
- Tech Transfer
- : Validation
- Master Validation Plan