Covance

Equipment Management Assoc IV

UK-Harrogate
Job Number
2017-15502
Job Category
Scientific Bachelor's Degree
Position Type
Full-Time

Job Overview

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 a Equipment Management Associate IV to join our growing team in Harrogate. 

  • 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.
  • Complete GMP quality records to an appropriate standard related to equipment failures and changes:
    • Deviations
    • Change Controls
    • CAPAs
    • Audit Comments
    • Compose documents from concept
      • Write IQ/OQ/PQ documents for internal execution
      • Compose SOPs and Policies as QDMS author
  • Serve as the subject matter expert (SME) and main point of contact for equipment / process
  • Arrange purchases for GMP EM Team or Operations
    • Gather quotes / contracts from appropriate service providers
    • Execute PO Requisitions / ePro submissions
  • Approve documentation completed by other associates with instrument knowledge confidence
  • Engage in improvement initiatives towards a singular process for all EM processes and documents.
  • Work on process harmonization across GMP sties (SOPs / IQOQPQ documents)
  • Coordinate / collaborate on continuous process improvements across GMP sites
  • Assist Global Business Technologies (GBT) and other areas of Global Laboratory Systems to assist in computer system validation (CSV) activities:
    • Determining the scope of the validation testing
    • Test script execution
  • Coordinate large project scopes to ensure proper execution and timely completion
  • Prioritize GMP EM Team function
    • Prioritize daily responsibilities of associates according to business needs
    • Determine associates area of GMP EM responsibility and determine cross training opportunities

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).
  • In-depth 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 must be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.

 

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