Validation Specialist

  • Location

    Holmes Chapel, Cheshire

  • Sector:


  • Job type:


  • Salary:


  • Contact:

    Anthony Duodu

  • Contact email:

  • Job ref:


  • Published:

    9 months ago

  • Duration:

    12 Months

  • Expiry date:


  • Client:


Validation Specialist
Holmes Chapel
12 months

Client Overview
The Client is a Swedish company, active as a pharmaceutical contract development and manufacturing organization, with production facilities in Sweden, France, Italy, Spain, Portugal, India and the UK as well as development sites in Sweden, Israel and USA.

For over 20 years we have focused on supporting pharmaceutical companies in taking their products from early development through to commercial manufacturing. Throughout the entire product lifecycle, we are there for our clients. Time and time again, we have delivered innovative solutions.

Role Overview
To develop and execute qualification and validation protocols (DQ, URS, RTM, FRA, FAT, SAT, IQ, OQ, PQ, PV, CV, CSV) and generate reports to support the implementation of site projects.

Key Skills Required
Ensures that all assigned qualification and validation activities are delivered in a timely manner to facilitate the delivery of Q&V projects to plan by:

  • Developing validation master plans, protocols and reports for DQ, FATS, SATS, FRA, RTM, IQ, OQ and PQ and to generate related summary reports
  • Execute installation, operational and performance qualification protocols and related documentation. Ownership of any related Q&V deviations to resolution and closure
  • Owning, initiating and updating as required Q&V related change controls, events, CAPAs and improvement actions
  • Support site engineering project managers in developing and reviewing and approving URS documents, specifications, assessments, acceptance criteria and test/inspection requirements and any other related validation procedures
  • Assist in pre-qualification commissioning activities

Additional Advantageous Requirements:

  • Have a recognised and relevant Scientific, Engineering or Technical Degree e.g. BSc, BEng
  • Experience in the Pharmaceutical industry, ideally working within a qualification and validation role supporting engineering projects or manufacturing and with experience of typical manufacturing and packaging plants and the equipment types found within a pharmaceutical environment
  • They should have a sound understanding of change control and qualification processes and the importance of GxP and HSE

Note: Assigned Q&V projects may involve the following activities:

  • Facility/utility qualification
  • Manufacturing equipment qualification
  • Packing line equipment qualification
  • Computerised system qualification
  • Process validation
  • Cleaning validation

Suitable candidates should submit their CV in the first instance