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Validation Engineer 6-12 Month Contract Keele

Adecco
Job LocationNewcastle-under-Lyme
EducationNot Mentioned
Salary50,000 - 65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Validation Engineer (Medical Device) Keele, £50,000-£65000I am currently recruiting for a Validation Engineer to join an international medical device company that engineers, manufactures and markets world leading products.Role responsibilities:The Validation Engineer role will primarily be accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations (CSV) and IT projects, in both a Medical Device and Pharmaceutical (cGMP) environment, including theSite Validation Master Plan (SVMP) and maintenance of such plan.

  • Prepare and issue Site Validation Master Plans (SVMP), Summary Reports and other required documentation for a validation exercise. Organise and lead validation activities to provide an effective validation service.
  • Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives, and schedules.
  • Provide validation leadership to ensure that all operations are carried out in compliance with regulatory and company requirements. Provide validation support and advice to other areas of the business as required.
  • Ensure projects relating to processes, facilities, equipment, cleaning, and CSV/IT validation are in compliance with regulatory and company requirements.
  • Provide specialist knowledge on validation of; process, facility, equipment, cleaning, and application of computer software used within production and service.
  • Promote effective working relationships and ensure they are maintained through the validation working party. Support a continuous improvement culture within the business.
  • Provide leadership, guidance, and direction to staff consistent with ISO13485, 21 CFR 820, and appropriate Pharmaceutical requirements.
  • Develop work plans, assign tasks, and supervise teams to achieve the overall site validation requirements.
  • Ensure staff have required knowledge and training when performing validation activities on department, site, processes, and procedures
  • Address site validation gaps via generation and completion of Site Validation Master Plans
  • Maintain site validation status according to regulatory requirements
  • Identify resource requirements and rate limiting steps within the Site Validation Master Plan
Role requirements:
  • Minimum 5 years Validation experience within Pharmaceutical/Medical Devices, including cleaning, analytical methods, lab equipment, computer system validation and re-qualification
  • Manufacturing process validation experience preferable, including the validation of new processes and changes to established processes using the lifecycle approach to validation
  • Proficient in Minitab or other alternative system and software packages Knowledge of Quality Management Systems
  • Level 6 within a science regulated industry or relevant experience
  • Level 5 in Leadership Management

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