Process Validation

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