Process Validation Lead
1 day ago
**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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Biotechnology Process Validator
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Linton, United Kingdom Capilaux Full time**Job Description**Capilaux is a leading biotechnology company seeking a highly skilled Biotechnology Process Validator to join our team and contribute to the successful validation of our products.The successful candidate will have extensive experience in process validation, project management, and compliance with industry standards and...
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