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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