Process Validation Lead

1 day ago


Linton, United Kingdom Capilaux Full time

**About Capilaux**

We are a leading biotechnology company seeking a skilled Process Validation Lead to support our success in the 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.

**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.
  • 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.

**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.

**Salary:** £60,000 - £80,000 per annum, dependent on experience and location. We are currently exploring this as a contract (outside of IR35) or as a permanent role.



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