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Cqv Engineer

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360 Resourcing Solutions

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Location:
United Kingdom , Keele

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

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Job Description:

The CQV Engineer (Commissioning, Qualification, and Validation) will primarily be accountable for the qualification and validation for Processes, Facilities, Equipment, and Computer System Validations in a Medical Device (cGMP) environment.

Job Responsibility:

  • Validation Activities: Organise and perform validation activities to provide an effective validation service
  • Compliance Documentation: Ensure all required documentation for a validation exercise, including validation protocols and summary reports, are created and maintained
  • SOP and Documentation Support: Provide input and technical expertise for the creation and revision of relevant Standard Operating Procedures (SOPs) and other quality \ Validation documentation
  • Project Alignment: Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules
  • Compliance Assurance: Ensure design projects relating to processes, facilities, equipment, and Computer System Validation are in compliance with regulatory and company requirements
  • Expert Advice: Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements
  • Specialist Knowledge: Provide specialist knowledge on validation of
  • process, facility, equipment and application of computer systems used within production and service
  • Continuous Improvement: Support a continuous improvement culture within the business

Requirements:

  • Level 6 within a science regulated industry or relevant experience
  • Minimum 3 years Validation experience within Pharmaceutical/Medical Devices, including cleaning, analytical methods, lab equipment, and computer system validation and re-qualification
  • Creation of validation protocols and reports
  • Knowledge of Quality Management Systems
  • Comprehensive knowledge and experience with the following industry regulations and guidance: FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), ISO 13485:2016 (Medical devices - Quality management systems), ALCOA+ principles for Data Integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ICH Q9 (Quality Risk Management) and its application to validation/qualification
  • Excellent communication skills
  • Ability to meet deadlines
  • Attention to detail
  • Demonstrate positive and enthusiastic attitude

Nice to have:

  • Manufacturing process validation experience preferable, including validation of new processes and changes to established processes using the lifecycle approach to validation
  • Proficient in Kneat or other alternative system and software packages
  • People management skills
  • Full, clean driving licence
  • Occasional overtime requirements
What we offer:
  • Company events
  • Company pension
  • Employee discount
  • Free or subsidised travel
  • Free On-site parking

Additional Information:

Job Posted:
March 01, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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