Process Validation Job

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Process Validation

Job Posted: 18 days ago

  • Salary: Competitive

    Job Type: Permanent Contract

  • Location: Cambridge, Cambridgeshire

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Expire in: 10 days

Job Description

Company: Biotechnology, Diagnostics Location: Hybrid in Cambridge Employment Type: Contract or Permanent About the Role: We are seeking a skilled Process Validation Lead to support a leading biotechnology company in the successful validation of processes for the production of a diagnostic medical device. The ideal candidate will be adept at managing end-to-end process validation projects within tight deadlines while ensuring compliance with industry standards and regulations. We are currently exploring this as a contract (outside of IR35) or as a permanent role. Salary will be dependent on experience and whether contract or permanent, but are inline with current market rates. Key Responsibilities: * Lead and execute process validation projects from initiation to completion. * Develop and implement validation master plans, protocols, and report templates. * Validate laboratory equipment, including basic and complex instruments such as pipettes, HPLCs, centrifuges, fridges, freezers, and spectrophotometers. * Ensure compliance with ISO 13485, cGMP guidelines, and related standards. * Collaborate with cross-functional teams and manage multiple stakeholders effectively. * Deliver projects within defined timelines, maintaining high attention to detail. Essential Requirements: * Significant experience conducting process validation in a laboratory setting under ISO 13485 or equivalent. * Proven ability to lead process validation projects independently. * Strong knowledge of ISO 13485 and cGMP guidelines. * Demonstrated expertise in writing validation master plans, protocols, and report templates. * Excellent communication and stakeholder management skills. * Strong organizational skills with the drive to meet tight deadlines. Desirable Qualifications: * Experience with risk-based qualification and QC process validation. * Advanced degree (Master’s or PhD) in Life Sciences or Engineering. * Background in enzyme manufacturing or the diagnostics industry. * Experience in project management and creating training materials. * Ability to conduct in-person training sessions. We are unable to provide sponsorship for this role. Please ensure that you have the right to work in the UK before applying
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