Equipment Validation Coordinator - Harrogate, North Yorkshire, UK
The BioCMC solutions Division, situated in Harrogate, North Yorkshire was established 20 years ago and is a fully GMP/ GLP/ GCP compliant facility providing a comprehensive portfolio of services including cell bank production and storage, cell bank and viral vector safety testing, viral clearance services, cell based bioassays, biodistribution studies, analysis of biofluids using immunochemistry based techniques and extensive protein chemistry support including cGMP batch release and stability testing. Recent major investments have been made in facilities on the Harrogate site and successful candidates will be part of our exciting and expanding future, working with progressive management, inventive technologies and alongside other talented scientists. We are looking to recruit an Equipment Validation Coordinator to join our growing team in Harrogate. Responsibilities/Duties Adhere to and/or complete all equipment documentation. This includes, but is not limited to: Standard Operating Procedures (SOP) Equipment Training Documentation Metrology Specification Requests (MSR) Equipment Qualification Documents (e.g., IOPQs, job tasks) Other equipment validation documents (e.g., risk assessments, URS, etc.) Supplier Approval Request Forms (SARF) Total Management System (TMS) Forms Work Orders Coordinate with in house or vendor maintenance and qualification activities: Work with Operations to determine appropriate timeframe for maintenance Schedule maintenance with Facilities Management (FM) Escort vendors during maintenance and qualification activities Ensure vendors meet GMP compliance requirements (i.e., approved supplier, training documents obtained, etc.) Manage “Do Not Use” tags to ensure instrumentation downtime is minimized Where required arrange for the installation and set-up of new equipment. Education / Qualifications The post holder should ideally have a relevant scientific degree and/or an appropriate amount of laboratory experience Experience The post holder should typically have: Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel). An understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), and an in-depth understanding of the GxPs. The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.